Tuesday, February 26, 2013
Monday, December 3, 2007
Bikini Hair Removal
Laser Hair Removal for Women
Bikini Hair Removal
Premiere Laser Centre is the best in Texas when it comes to bikini procedures. It is one of our specialties. Our two most popular styles are:
French Bikini
A very low cut bikini line that includes the hair from the belly button down to the pubic area (linea negra). The hair is also removed from the panty line down three finger widths on the inside of the thigh. We also treat the lower edge of the buttocks (the area that may show under a swimsuit). The resulting shape is a dainty "V" shape that will allow you to comfortably wear almost any little bikini bottom.
Premiere Girl Bikini
It's the whole thing. We remove all the hair
from the belly button to the baby bottom including the genitalia. Most girls choose to leave the "landing strip" or a petite "V" at the front. The resulting shape is sexy and smooth. Women love the clean feeling they have after having the hair removed from their most private areas. And, we get a lot of "thank yous" from the men in their lives.
Laser Hair Removal Frequently Asked Questions
Laser Hair Removal Imagine having smooth, hair free skin without shaving, waxing, plucking, or bleaching your unwanted hair. We now offer safe, fast, effective, and affordable Laser Hair Removal Services.
How does Candela GentleYag® hair removal work?
The Candela GentleYag laser is a non-invasive light therapy device specifically designed to eliminate unwanted hair from all parts of the body. The Candela GentleYAG generates a pulse of intense, concentrated light which is directed through a small handpiece when it is applied to the treatment site.
This laser energy passes through the skin to the hair follicle, where the energy is absorbed by pigment in the hair and hair follicle, causing selective damage to the hair root without damaging delicate pores and structures of the skin. The laser is pulsed, or “turned on”, for only a fraction of a second. The duration of the pulses is carefully calibrated so that laser energy will be absorbed by the hair follicle without transferring excessive heat to the surrounding skin. Some of the hair which was in the treated follicles is ejected during treatment, and the rest is shed over the next 2-3 weeks.
The surface of the skin is protected by the Dynamic Cooling Device. This device sprays a short burst of cryogen to the skin to cool and protect the epidermis. The spray is computer calibrated to work with your skin type. This protects the skin while effectively treating the unwanted hair. Unlike “hair-by-hair” treatments with electrolysis, the laser uses a wide beam which treats many hairs at once. Because the Candela GentleYag can treat dozens of hairs with each pulse, it is possible to treat larger areas such as the back, shoulders, arms, legs and face. The Candela GentleYag can be used just about anywhere on the body. Even sensitive areas such as the nipples, upper lip and bikini line can be treated easily. The laser’s design allows us to customize treatment, according to your hair and skin color, hair texture, and location on the body.
Candela GentleYag treatment is a safe, fast, gentle and effective method for hair removal. In just a few treatment sessions using the gentle power of laser, you can greatly improve the appearance of skin which is disfigured by unwanted hair.
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What areas of the body can be treated?
ALL parts of the body can be treated with the laser. In women, the most common areas for treatment are upper lip, chin, bikini line, arms and legs, and underarms. In men, the most common areas for treatment are shoulders and back, and the beard area.
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How does laser hair removal compare to other treatments?
The primary benefits of laser hair removal include:
Larger areas may be treated with less discomfort than with electrolysis, waxing or tweezing.
The Candela GentleYag combines speed, comfort and long lasting results.
The Candela GentleYag works on any area of the body where a hair-free appearance is desired.
The laser is safe for use on pregnant women — who respond well because their hair is often thicker and darker during pregnancy. We can treat any area of the body on pregnant women except the lower abdominal area. We do not believe that there is a danger to the fetus but we choose not to take any chances at all.
Shaving, waxing and depilatory creams remove the hair but leave the hair follicles intact, so the hair regrows within one to four weeks in most cases. Candela GentleYag laser hair removal offers you a long-term reduction in both the amount of hair, and also in many cases a reduction in thickness and color of hair shafts which do grow back.
Hair removal methods like tweezing, waxing or sugaring which cause irritation may actually stimulate hair growth. This happens because one way the body defends itself against having hair yanked out is to produce thicker, stronger hairs which are harder to pull out next time. Laser hair removal offers long lasting results, and even if hair does eventually grow back it is usually finer in texture and lighter in color than the original hair, and much less of a cosmetic problem.
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What are the advantages over electrolysis?
Removing hair by electrolysis is like mowing grass — one blade at a time. With electrolysis, the operator inserts a needle (probe) into the hair follicle and tries to have the tip reach the hair root. The operator then triggers a small electrical charge to damage the hair root. The hair from that follicle is then removed with tweezers.
Electrolysis can be an excellent technique for the removal of of small numbers of hairs, from areas where it is difficult to use the laser (under the eyebrows, near the eyes, and in the ears and nose) and white and very pale blonde hair (which does not absorb laser light efficiently). We refer patients for electrolysis if we believe the laser cannot be of help, or after we have removed all of the dark hairs that are treatable with the laser.
There can be considerable variation in the results between electrolysis, and the rate of permanent hair loss has been reported to be from 15 to 50%. Electrolysis is a tedious process and a difficult undertaking for patients. Even a small area like the face, for example, in the case of a woman with heavy facial hair, may require electrolysis for 2 –3 hours per week for 2 years, with further treatments over an undetermined period of time, for a total treatment time exceeding 200 hours. Hair removal is much faster with a laser because each “pulse” of laser light disables a large numbers of hair follicles, and pulses can be delivered as often as once every second. Electrolysis operators can only treat hairs they can see. The laser treats all “active” follicles, even if the hair has not yet reached the surface of the skin, is “ingrown”, or if the hair shaft is not straight.
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Everyone wonders: “How much does it cost?”
Laser hair removal can be surprisingly affordable. When time is at a premium, laser can produce fast results ultimately at a fraction of the cost of electrolysis. We do not publish our price list because there is a big variation in costs to treat different people. For example, removing the hair from the legs of a woman who is 5 feet tall takes less time than a woman who is 5 feet 8 inches tall. People come in different sizes and shapes. Treatment protocols and prices are highly individualized. We price accordingly.
We offer a free consultation with free spot test to make sure you are a good candidate for laser hair removal. At that time, measurements are taken to determine the actual cost per treatment and a treatment plan is arranged for you at that time. Many of our clients have gotten bids from our competitors and have returned here because our prices are better and they feel more comfortable at our center.
At Premiere Laser Centre, you receive the benefit of caring, highly skilled technicians who put your safety and comfort first. We accept Visa, MasterCard, Discover, check or cash. Financing is available for package programs with approved credit from Cosmetic Fee Plan.
There is no charge for your first consultation and spot test. Consultations about laser can usually be arranged within a week by calling us at (940) 320-5432 where our staff who have had laser hair removal themselves can take the time to discuss your wishes and options, and answer your questions. No referral is required. Treatment may be scheduled within a few days of your spot test.
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Is laser hair removal covered by insurance?
Most private insurance companies do not offer reimbursement for “cosmetic” procedures like laser hair removal; however, consult your insurance carrier for more information. The removal of unwanted terminal hair for the management of hirsutism, congenital or drug-related hypertrichosis, pseudo-folliculitis, transsexual states, and some skin grafts may be covered by some private insurance plans. We do not file for insurance reimbursement.
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Is the cost of laser hair removal a tax deductible medical expense?
Laser hair removal is not a tax deductible medical expenditure UNLESS the hair is part of a genetic or hormonal condition where laser hair removal is prescribed by a doctor. Please check with your accountant or with the IRS for more information.
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What are the risks of laser hair removal?
Short-term side effects may include a slight reddening of the skin or local swelling which typically lasts less than an hour, although it may infrequently last a few days. Rarely (perhaps 2-4 cases out of a hundred) there can be increased or decreased pigment in the treated area. This is seldom a major cosmetic problem, and generally resolves after a few months. Even a single blister (rather like a tiny sunburn) is very rare (less than one in a hundred). The light from the Candela GentleYag does not cause skin cancer.
Unlike plucking, waxing and sugaring, laser hair removal does not run the risk of making hair grow back thicker, darker or quicker. After laser treatment hair growth will frequently be delayed, AND when hair does grow back, it is often lighter, finer and less dense.
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Is laser hair removal "permanent"?
" “Permanent hair removal” means: “ALL the hair is gone, FOREVER!”
There is NO hair removal method (including laser) which can guarantee “permanent hair removal”. The most realistic description of the results after laser treatment is: “long-term hair REDUCTION”. This means: “After four to six treatments the total amount of hair is greatly reduced — generally by 70% to 90% — and hair which does grow is often much finer and lighter in color.” Most people are very pleased with this degree of improvement, as long as they know that this is what to expect before they have laser hair removal treatment. You must realize that after having between four and six treatment sessions it is VERY LIKELY that there WILL BE a very substantial reduction in both the amount of hair and also a reduction in the thickness and color of the hair in the treated areas. You should expect that this reduction in hair may last for many years. Because lasers have been used for hair removal for only the last seven years, we cannot know if the results will continue to be felt in 10 or 20 years. However, we do know that stable, long-term hair reduction commonly lasts for at least two years, and some patients who had their last treatment six or seven years ago are still enjoying a high degree of hair reduction.
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Should I expect to be "hair free" in the treated area after the series of treatments?
No, most patients experience an 80-90% reduction in the amount of hair in a given area, and a reduction in the thickness and color of the remaining hair, but should not expect to be “hair free”.
It has been suggested that a 6 month follow-up may be sufficient to assess final outcome after the final laser hair removal session, because once regrowth had stabilized (usually within 6 months), there is usually little or no change in hair counts at 6,12, and 24 months.
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How much hair will grow back, and how fast will it grow back?
Lasers work by destroying hair roots which are active at the time of treatment, and which have enough pigment to absorb sufficient laser energy. The hair shafts in the treated hair follicles will fall out, or be “shed” 1-3 weeks after treatment.
After the first treatment, hair regrowth may resume within a few weeks or it may be anywhere from 2-4 months before any true hair growth is observed, as previously dormant hair follicles become active, and hair follicles which were stunned but not killed recover and start to produce hair shafts again. Some people find that there is not much extra hair reduction after the second treatment, then they notice a substantial further reduction after the third or more commonly the fourth treatment. After four to six treatments there may be little or no regrowth for many years. In other cases you may wish to have additional treatment after a period of time.
Hairs that regrow after laser treatment generally are finer and lighter in color, and so are much less of a cosmetic problem. Reductions in coarseness and color can occur independently of each other.
New terminal hair appearing in androgen sensitive sites (face, axillae and genital area) after successful laser epilation could result from androgen stimulated conversion of previously dormant vellus hairs, which are not affected by the laser as long as they remain dormant and unpigmented.
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Why are at least 3-6 treatment sessions usually needed?
All lasers work by disabling hairs that are in their active growth cycle at the time of treatment. Hair follicles in their “dormant” phase have no hair shaft in them and so will not be affected by the laser. Because hair follicles cycle through “active” and “dormant” phases, additional sessions are usually desired once the “dormant” follicles become “active”, and also to deal with hair follicles which were stunned but not killed by previous treatment. The other group of hair follicles which could produce dark terminal hair in the future are the fine vellus “peach fuzz” follicles which have no pigment and so are not affected by laser treatment. If some of these fine little “peach fuzz” follicles mature into terminal hair follicles, they can be treated with laser at that time.
There is NO treatment which will kill 100% of the hair follicles, 100% of the time. Laser hair removal is not an exact science because there are so many variables. Your laser technician can discuss “averages” and give you an estimate of the number of treatments based on past experience.
At any one time, 50 to 85% of your hair follicles are in the active (anagen) phase but only 1/4 to 1/3 of your hairs have enough of the pigment in their ROOTS to absorb the laser beam which destroys the hair root. So, about 1/4 to 1/3 (25% to 33%) of your hair roots are good targets for the laser beam, and can be damaged or destroyed in a single laser session.
Because 1/4 to 1/3 of the actively growing pigmented hair roots are damaged or destroyed in any one session, almost all people will want a minimum of three to four treatments to reach a satisfactory degree of hair reduction, and many people will wish to have more than four treatments, most commonly 5 to 8 treatments; and in some cases another session in six to twelve months to eliminate any terminal hairs which have developed when vellus hair follicles mature into terminal hair follicles.
The number of treatments depends on:
the desired degree of hair reduction (as the amount of hair declines, some people become very enthusiastic and want even LESS hair than they had originally planned).
hair color (people with naturally light colored hair need more treatments)
ethnic and genetic background (people with dark skin sometimes need more treatments).
hormonal status
area being treated
hair density
age
weight (obesity can increase hair growth)
medication (for example medicines like Dilantin and cyclosporine can increase hair growth)
Additional “touchup” treatments on small troublesome areas are treated at reduced rates There is no safety limit on the number of treatments a person can have. People who have been partially treated with other types of hair removing laser might in some cases need less than 3 laser treatments to reach a satisfactory degree of long-term hair reduction.
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Previous laser treatment or electrolysis? No problem!
Candela GentleLASE has been successfully used on many people who were not able to tolerate - or did not obtain satisfactory results with electrolysis, or with older laser and "high intensity light" systems, including ruby laser, and Epilight™ systems.
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Am I a good candidate for laser hair removal?
The unique design of the Candela GentleYag allows treatment of people with most skin colors up to and including African American skin types and people with tanned skin. Because hair which is naturally blonde, light red or white does not have enough pigment in the roots, it cannot be reliably treated with any type of laser. Children can be treated, for example if they have a congenital nevus or other problem with excessive hair, but the children must be old enough (for example, 12 years old) to understand and cooperate with treatment. We frequently treat young, preteen girls who have develolped dark hair on the upper lips.
Laser hair removal is not just for “cosmetic” problems. Patients with excess hair because of medications (i.e., organ transplant patients who are taking cyclosporine) can benefit from laser hair removal; as can patients who have problems with ingrown hair and folliculitis under prosthetic devices.
Many people at some time before laser hair removal have fears and doubts. A common concern is that they are being vain. Most patients who have laser hair removal are no more vain than anyone else. What does distinguish them is a desire to get the most out of life. Looking after our appearance is not a fault. After all would you leave your house with broken gutters or peeling paint? Why do less for your body? You should feel proud of yourself for having the courage to want to change something that you find unacceptable. Normal, reasonable people who have realistic expectations tend to be excellent candidates for laser hair removal treatments.
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Which hair colors respond best to treatment?
Because lasers target the PIGMENT in hair roots, lasers work best on black or brown hair. Light brown or auburn hair may require more treatment sessions. White hair does not respond to treatment — so get your hair removed before you get old and your hair turns white!
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Questions to ask yourself when considering laser hair reduction:
How much are you bothered by your facial hair? Hair on other areas?
How much are you bothered by the time you spend removing, treating, or concealing your facial hair? Hair on other areas?
How uncomfortable does your facial or other unwanted hair make you feel in exchanges of affection (such as intimate exchanges with your partner)?
How uncomfortable does your unwanted hair make you feel when you meet new people?
How uncomfortable does your unwanted hair make you feel when you go to social gatherings, dine out in a public restaurant, go to a supermarket or other public place?
How uncomfortable does your unwanted hair make you feel when you go to work or class?
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What are Hirsutism and Hypertrichosis?
Hirsutism is excessive growth of hair in androgen (testosterone) -dependent areas of a woman’s body where terminal hair is not normally found, including the face, neck, chest or medial thighs.
Hypertrichosis is excessive growth of hair in non-androgen dependent parts of the body (i.e.. Areas other than the face, neck, chest and medial thighs).
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What is Unwanted Female Facial Hair?
Growth of hair on the face which is coarser, longer or more profuse than is “normal” for the age and race of the woman. Unwanted Facial Hair is a chronic problem for about 22 million American women who remove facial hair at least once a week.
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How can I get the best value from each treatment?
To get the best results with the smallest number of treatment sessions, please pay attention to the following guidelines as you work with us:
A. Avoid waxing / sugaring / plucking / EpiLady and electrolysis
Because the laser beam seeks out and destroys ACTIVELY GROWING hair roots, it is important (if you want to get the best value from your treatment) NOT to wax / pluck / sugar / use EpiLady-type pluckers or have electrolysis for at least two weeks before laser treatment. These things temporarily remove the pigmented part of the hair follicle which the laser needs to use as a target when it destroys the hair follicle.
B. Please avoid tanning!
The Candela GentleYag is safe and effective laser for most types of skin. Many Italian, Greek, and East Asian have been successfully treated with the Candela GentleYag laser. BUT: the lighter your skin color at the time of treatment, the better the laser beam can get through the skin to the hair roots, where it is needed. If you avoid tanning and stop using artificial “tanning” creams for six weeks before treatment, you will get the maximum possible benefit from each treatment session. People with very darker skin should also take precautions in the sun and wear a sunscreen between sessions.
It is also a good idea to minimize tanning for a few weeks after laser treatment, to reduce the chance that your tan will be somewhat uneven. Protect yourself by using a sunscreen on all treated areas before, during and after treatments.
C. Shaving or clipping the hair? Good idea!
Shaving or clipping the area to be treated is not a problem. In fact, we like the areas to be shaved the day of treatment or the day before. Some people find that the skin is less sensitive if it is shaved at least a few hours before treatment. Another advantage of shaving the area to be treated BEFORE you come in is that YOU can shape the area to be treated exactly the way YOU want it to be. This is of particular importance in areas like the sideburns, temples, and bikini line / bikini area.
Excess hair must be removed from the treatment area before treatment, because hair ABOVE the surface of the skin will simply absorb and waste laser energy and keep it from getting to the hair roots, where it is needed. If you do not wish to shave the area, our technicians will do it for you.
Contrary to popular belief, shaving DOES NOT make hair grow back thicker, faster, darker or more profusely! So go ahead and shave before treatment, and between treatments!
D. Bleaching? No problem!
Because the laser beam only acts on the hair ROOTS, it is OK to bleach hair in the areas to be treated because bleaching will not affect the color of the roots. We do prefer that you stop bleaching before your first visit so that we can see the hair to be treated and give you an accurate evaluation.
E. Timing
It takes 4 to 8 weeks for the next crop of hair roots to become active and develop pigment which is the target for the laser. So, to get the best value from your treatments, you treatments will be scheduled at 4-8 weeks intervals. There is no harm in having treatments MORE FREQUENTLY than every 4-8 weeks, or having treatments less than 4 weeks after waxing, plucking, etc. — but this is less efficient, and could increase the total number of treatments needed to get a good result. Also, while there is no harm in waiting MORE THAN 4-8 weeks between treatments (for example, if there has not been much regrowth after your last treatment), there is usually no extra BENEFIT to waiting longer than 6-12 weeks between treatments.
F. Medications?
There are a few medications which should not be taken while you are getting laser treatment. Anabolic steroids should certainly NOT be taken unless medically necessary, because these can increase male-pattern hair growth in some cases. We cannot treat you if you are presently or have recently used Accutane or Bactrim. Women who take injections of Climacteron (testosterone & estradiol) as part of therapy for menopause and to increase libido often experience unwanted hair growth, which can be treated with laser hair removal.
Medicines which inhibit hair growth (for example, spironolactone, Diane-35 birth control pills, Euflex, Androcur and Vaniqa cream) might slightly reduce the pigment in hair roots and make laser treatment less efficient, but this seldom interferes with the effectiveness of laser treatment. Laser hair removal can certainly be done WHILE you are on those medicines, if you wish. These “anti-androgenic” medicines produce gradual but temporary effects, and will not remove unwanted hair from areas that are independent of androgen regulation.
Pretreatment with medicines like Acyclovir, Valtrex or Famvir may be necessary if you tend to get cold sores in the area to be treated.
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What is a “test area”, and why is it performed?
Test areas” are small areas of skin that are treated at various laser energy levels prior to treatment. “Test areas” are to determine the level of energy that is best for that individual. On darker skin types, these tests are reviewed one week later to make sure there was no burning or pigment change. Light skin types generally do not have to have wait because test results are fairly rapid. This may be done at the same time as your consultation.
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Moles, freckles and tattoos in the area to be treated?
Small moles and freckles do not require special precautions. Large, dark moles and freckles which are to be treated will require a reduction in the intensity of the laser light, the same way that the intensity would be reduced when treating a dark-skinned or tanned person. We do not treat tattoos, but this is seldom a problem because quite often there is not much hair growth in tattoos. Be sure to tell us if you have permanent lip liner or permanent eyebrows, because these are tattoos and special precautions are needed if there will be laser treatment near those areas.
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What will happen on the treatment day?
HELLO LASER, GOOD-BYE RAZOR!
Lasting hair removal has never been this easy! Other than your regular skin care routine, there is no standard “prep” for this procedure. Please do not wear makeup on the areas to be treated, because some kinds of makeup can absorb and waste laser energy, or even heat up to the point where your skin would be irritated. Makeup will need to be removed before treatment, and may be reapplied after two hours. Do not apply vaseline, lip balm or other heavy petroleum based products on the area to be treated. There are no restrictions on what you may eat or drink prior to your appointment.
Please do not shave the area to be treated on the day of your treatment. We like to see a small amount of hair to determine regrowth patterns.
After all of your last minute questions have been answered and paperwork handled, the areas you wish to have treated will be cleansed and pretreatment photos may be taken. Everyone in the treatment room must wear protective goggles when the laser is turned on. The Candela GentleYag is a high powered laser system, and can cause eye injury if proper eye wear is not worn.
The length of the procedure itself can range from a few minutes for the upper lip to an hour or more (for example, a man’s chest or back).
If you decide before coming in that you would like to have additional areas treated, please call ahead so that we can schedule enough time to accommodate your needs.
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Does it hurt?
The laser emits only light. You may feel a tingling or snapping sensation like a rubber band. There is no bleeding and no open wound is created. Some people find the FIRST laser treatment more uncomfortable than subsequent treatments. This is because there are more hair roots which are destroyed during the first treatment; and perhaps also because some people are more apprehensive during the first treatment, because they are not sure of what to expect.
While some areas of the body like the upper lip and pubic hair area are more sensitive than others, many patients report little or no discomfort. Your technician is well-trained in discomfort management techniques and will prepare your treatment accordingly. If you are scheduled to have topical anesthetic applied, ample time will be allowed. People who have had waxing, sugaring, and/or electrolysis (or treatment with other lasers) usually report that Candela GentleYag causes less discomfort, and sometimes there is almost no discomfort.
The Candela GentleYag features the Dynamic Cooling Device (DCD). This device sprays a short burst of cryogen to the skin a split second prior to pulsing. This coolant protects the skin and makes the treatment more comfortable for you. The cooling spray can be adjusted to suit your skin type and hair type and is computer calibrated for carefully controlled delivery.
We use a prescription strength topical anesthetic gel in very sensitive areas or by those who think they have a very low pain threshold. A decision to use topical is determined at your initial consultation visit. Some people find it helpful to take two or three plain Tylenol and/or Advil a couple of hours before coming in for treatment. Some women find that they are more sensitive during their menstrual cycles, however, this would not preclude treatment.
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What will happen after treatment?
Generalized redness and edema are quite common after treatment. These symptoms usually subside within an hour or so. Some patients report redness lasting for up to 48 hours which is still within acceptable norms. In most cases, redness has faded greatly by the time you get home. It would not be uncommon for the skin to be slightly drier that evening. Premiere recommends using Aloe Vera and Dr. Berman’s moisturizer. Your technician will give you small jars of aftercare products to use that evening. There are no limitations to your activities, however, we ask that you do not take a hot shower or bath for the first day. We will ask you not to workout or engage in any physical activity that may cause sweating for the first 24 hours. Our experience has shown that better results are achieved with less irritation when you do not reheat the skin with hot water or exercise.
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Why does the hair sometimes look like it’s “growing” for 1-3 weeks after laser treatment?
Lasers destroy hair roots which are active at the time of treatment, but do not remove hair shafts instantly. Hair shafts in the treated hair follicles will fall out, or be “shed” mostly in the first week after treatment, with all of the treated hairs falling out within 2-3 weeks. It is normal that some hairs in the treated area may not fall out within 2-3 weeks. These will treated in the next session.
These hairs which are being shed will come out on their own. It is best not to shave the treated area. If the skin is irritated, use only soft wash clothes and mild soap and moisturizing creams. You may use exfoliating gloves in the treated area but it is not really necessary.
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Are there any restrictions on my activity after treatment?
Since the laser does not burn or cut the skin in any way, no bandages are necessary. You can return to work the same day and resume all your regular activities. Please do not tan the skin or use tanning creams between treatments. Tanning between treatments can increase the risk of hyperpigmentation and uneven skin coloration. It is OK to resume shaving or clipping hair in the treated area after 3-4 days. Do not tweeze, wax or sugar the hair between treatments. In the bikini area, it is best not to shave at all between treatments to avoid ingrown hair problems.
Shaving really is the BEST temporary way to remove unwanted hair before and between laser treatments. Shaving leaves the hair SHAFT in the hair follicle, so the hair shaft can be a target for laser energy, heat up and KILL the hair follicle.
You can shave as often as you want. It has been shown in scientific studies that:
Shaving does NOT make hair grow faster.
Shaving does NOT make hair grow thicker.
Shaving does NOT make hair grow darker.
Shaving does NOT make hair grow more profusely.
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Pre-treatment instructions:
Please do not wax or tweeze the hair for 2-3 weeks before treatment, because hair follicles which do not have hair shafts in them to absorb laser energy will not be killed by the laser energy.
Please stop tanning immediately. A fresh tan can interfere with the effectiveness of the treatment and possibly even cause complications. Tell is if you have tanned recently. We cannot treat you if you have been tanning within the ten day period before your treatment.
You may shave or clip the areas to be treated the day before treatment or on the morning of treatment. Shaving before you come in also allows you to shape the exact area you want treated — this is sometimes very useful in areas like the hairline and sideburns, and in the bikini area. Excess hair above the surface of the skin absorbs and wastes laser energy, and reduces the amount of energy that reaches the hair root, where it is really needed. Excess hair above the surface of the skin also increases the chance of burning or irritating the skin.
Some people find it helpful to simply take 2 or 3 Tylenol and/or Advil 2 hours before coming in for treatment. Some women who find that they are less sensitive after their menses prefer to schedule their treatment sessions to avoid the premenstrual and menstrual time. During the treatment, remember that we care about your comfort. Unexpected discomfort is nature’s way of telling us something is wrong, so please tell us and we will go slower, apply more cooling, or adjust the power of the laser for you.
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Pre-treatment instructions:
Redness often has faded greatly by the time you get home. It would not be uncommon for the skin to be slightly drier that evening and to require more of your favorite moisturizer. We recommend Dr. Andrew Berman’s Aboriginal Gold which can be purchased at the center. The hair follicles may appear slightly more obvious or a bit pink for the next day or two, but this is seldom a cosmetic problem, and generally much less obvious than after waxing shaving.
Do not tan or use tanning creams between treatments. If you must be in the sun, please wear a sunscreen of 30 SPF or higher and apply it frequently if you are swimming or perspiring.
Hair shafts will be released from hair follicles in the treated area for a week or two after treatment. You do not need to do anything, but you may gently exfoliate or shave the areas if you wish.
Shaving, is OK between laser treatments. Tweezing, waxing and sugaring should be avoided because these things could reduce the effectiveness of your next laser treatment.
Blistering or scaling after GentleYag laser hair removal is very uncommon, but usually resolves over a few days or a week with a bit of Polysporin cream several times a day. Please call us if this happens, or if you have any other problems or questions.
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How do I get started?
Consultations can be arranged within a week simply by calling us at metro (940) 320-5432. Treatment can scheduled within a few days of consultation. Our technicians will take the time to discuss your wishes and options, and answer your questions.
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How does Candela GentleYag® hair removal work?
The Candela GentleYag laser is a non-invasive light therapy device specifically designed to eliminate unwanted hair from all parts of the body. The Candela GentleYAG generates a pulse of intense, concentrated light which is directed through a small handpiece when it is applied to the treatment site.
This laser energy passes through the skin to the hair follicle, where the energy is absorbed by pigment in the hair and hair follicle, causing selective damage to the hair root without damaging delicate pores and structures of the skin. The laser is pulsed, or “turned on”, for only a fraction of a second. The duration of the pulses is carefully calibrated so that laser energy will be absorbed by the hair follicle without transferring excessive heat to the surrounding skin. Some of the hair which was in the treated follicles is ejected during treatment, and the rest is shed over the next 2-3 weeks.
The surface of the skin is protected by the Dynamic Cooling Device. This device sprays a short burst of cryogen to the skin to cool and protect the epidermis. The spray is computer calibrated to work with your skin type. This protects the skin while effectively treating the unwanted hair. Unlike “hair-by-hair” treatments with electrolysis, the laser uses a wide beam which treats many hairs at once. Because the Candela GentleYag can treat dozens of hairs with each pulse, it is possible to treat larger areas such as the back, shoulders, arms, legs and face. The Candela GentleYag can be used just about anywhere on the body. Even sensitive areas such as the nipples, upper lip and bikini line can be treated easily. The laser’s design allows us to customize treatment, according to your hair and skin color, hair texture, and location on the body.
Candela GentleYag treatment is a safe, fast, gentle and effective method for hair removal. In just a few treatment sessions using the gentle power of laser, you can greatly improve the appearance of skin which is disfigured by unwanted hair.
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What areas of the body can be treated?
ALL parts of the body can be treated with the laser. In women, the most common areas for treatment are upper lip, chin, bikini line, arms and legs, and underarms. In men, the most common areas for treatment are shoulders and back, and the beard area.
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How does laser hair removal compare to other treatments?
The primary benefits of laser hair removal include:
Larger areas may be treated with less discomfort than with electrolysis, waxing or tweezing.
The Candela GentleYag combines speed, comfort and long lasting results.
The Candela GentleYag works on any area of the body where a hair-free appearance is desired.
The laser is safe for use on pregnant women — who respond well because their hair is often thicker and darker during pregnancy. We can treat any area of the body on pregnant women except the lower abdominal area. We do not believe that there is a danger to the fetus but we choose not to take any chances at all.
Shaving, waxing and depilatory creams remove the hair but leave the hair follicles intact, so the hair regrows within one to four weeks in most cases. Candela GentleYag laser hair removal offers you a long-term reduction in both the amount of hair, and also in many cases a reduction in thickness and color of hair shafts which do grow back.
Hair removal methods like tweezing, waxing or sugaring which cause irritation may actually stimulate hair growth. This happens because one way the body defends itself against having hair yanked out is to produce thicker, stronger hairs which are harder to pull out next time. Laser hair removal offers long lasting results, and even if hair does eventually grow back it is usually finer in texture and lighter in color than the original hair, and much less of a cosmetic problem.
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What are the advantages over electrolysis?
Removing hair by electrolysis is like mowing grass — one blade at a time. With electrolysis, the operator inserts a needle (probe) into the hair follicle and tries to have the tip reach the hair root. The operator then triggers a small electrical charge to damage the hair root. The hair from that follicle is then removed with tweezers.
Electrolysis can be an excellent technique for the removal of of small numbers of hairs, from areas where it is difficult to use the laser (under the eyebrows, near the eyes, and in the ears and nose) and white and very pale blonde hair (which does not absorb laser light efficiently). We refer patients for electrolysis if we believe the laser cannot be of help, or after we have removed all of the dark hairs that are treatable with the laser.
There can be considerable variation in the results between electrolysis, and the rate of permanent hair loss has been reported to be from 15 to 50%. Electrolysis is a tedious process and a difficult undertaking for patients. Even a small area like the face, for example, in the case of a woman with heavy facial hair, may require electrolysis for 2 –3 hours per week for 2 years, with further treatments over an undetermined period of time, for a total treatment time exceeding 200 hours. Hair removal is much faster with a laser because each “pulse” of laser light disables a large numbers of hair follicles, and pulses can be delivered as often as once every second. Electrolysis operators can only treat hairs they can see. The laser treats all “active” follicles, even if the hair has not yet reached the surface of the skin, is “ingrown”, or if the hair shaft is not straight.
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Everyone wonders: “How much does it cost?”
Laser hair removal can be surprisingly affordable. When time is at a premium, laser can produce fast results ultimately at a fraction of the cost of electrolysis. We do not publish our price list because there is a big variation in costs to treat different people. For example, removing the hair from the legs of a woman who is 5 feet tall takes less time than a woman who is 5 feet 8 inches tall. People come in different sizes and shapes. Treatment protocols and prices are highly individualized. We price accordingly.
We offer a free consultation with free spot test to make sure you are a good candidate for laser hair removal. At that time, measurements are taken to determine the actual cost per treatment and a treatment plan is arranged for you at that time. Many of our clients have gotten bids from our competitors and have returned here because our prices are better and they feel more comfortable at our center.
At Premiere Laser Centre, you receive the benefit of caring, highly skilled technicians who put your safety and comfort first. We accept Visa, MasterCard, Discover, check or cash. Financing is available for package programs with approved credit from Cosmetic Fee Plan.
There is no charge for your first consultation and spot test. Consultations about laser can usually be arranged within a week by calling us at (940) 320-5432 where our staff who have had laser hair removal themselves can take the time to discuss your wishes and options, and answer your questions. No referral is required. Treatment may be scheduled within a few days of your spot test.
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Is laser hair removal covered by insurance?
Most private insurance companies do not offer reimbursement for “cosmetic” procedures like laser hair removal; however, consult your insurance carrier for more information. The removal of unwanted terminal hair for the management of hirsutism, congenital or drug-related hypertrichosis, pseudo-folliculitis, transsexual states, and some skin grafts may be covered by some private insurance plans. We do not file for insurance reimbursement.
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Is the cost of laser hair removal a tax deductible medical expense?
Laser hair removal is not a tax deductible medical expenditure UNLESS the hair is part of a genetic or hormonal condition where laser hair removal is prescribed by a doctor. Please check with your accountant or with the IRS for more information.
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What are the risks of laser hair removal?
Short-term side effects may include a slight reddening of the skin or local swelling which typically lasts less than an hour, although it may infrequently last a few days. Rarely (perhaps 2-4 cases out of a hundred) there can be increased or decreased pigment in the treated area. This is seldom a major cosmetic problem, and generally resolves after a few months. Even a single blister (rather like a tiny sunburn) is very rare (less than one in a hundred). The light from the Candela GentleYag does not cause skin cancer.
Unlike plucking, waxing and sugaring, laser hair removal does not run the risk of making hair grow back thicker, darker or quicker. After laser treatment hair growth will frequently be delayed, AND when hair does grow back, it is often lighter, finer and less dense.
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Is laser hair removal "permanent"?
" “Permanent hair removal” means: “ALL the hair is gone, FOREVER!”
There is NO hair removal method (including laser) which can guarantee “permanent hair removal”. The most realistic description of the results after laser treatment is: “long-term hair REDUCTION”. This means: “After four to six treatments the total amount of hair is greatly reduced — generally by 70% to 90% — and hair which does grow is often much finer and lighter in color.” Most people are very pleased with this degree of improvement, as long as they know that this is what to expect before they have laser hair removal treatment. You must realize that after having between four and six treatment sessions it is VERY LIKELY that there WILL BE a very substantial reduction in both the amount of hair and also a reduction in the thickness and color of the hair in the treated areas. You should expect that this reduction in hair may last for many years. Because lasers have been used for hair removal for only the last seven years, we cannot know if the results will continue to be felt in 10 or 20 years. However, we do know that stable, long-term hair reduction commonly lasts for at least two years, and some patients who had their last treatment six or seven years ago are still enjoying a high degree of hair reduction.
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Should I expect to be "hair free" in the treated area after the series of treatments?
No, most patients experience an 80-90% reduction in the amount of hair in a given area, and a reduction in the thickness and color of the remaining hair, but should not expect to be “hair free”.
It has been suggested that a 6 month follow-up may be sufficient to assess final outcome after the final laser hair removal session, because once regrowth had stabilized (usually within 6 months), there is usually little or no change in hair counts at 6,12, and 24 months.
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How much hair will grow back, and how fast will it grow back?
Lasers work by destroying hair roots which are active at the time of treatment, and which have enough pigment to absorb sufficient laser energy. The hair shafts in the treated hair follicles will fall out, or be “shed” 1-3 weeks after treatment.
After the first treatment, hair regrowth may resume within a few weeks or it may be anywhere from 2-4 months before any true hair growth is observed, as previously dormant hair follicles become active, and hair follicles which were stunned but not killed recover and start to produce hair shafts again. Some people find that there is not much extra hair reduction after the second treatment, then they notice a substantial further reduction after the third or more commonly the fourth treatment. After four to six treatments there may be little or no regrowth for many years. In other cases you may wish to have additional treatment after a period of time.
Hairs that regrow after laser treatment generally are finer and lighter in color, and so are much less of a cosmetic problem. Reductions in coarseness and color can occur independently of each other.
New terminal hair appearing in androgen sensitive sites (face, axillae and genital area) after successful laser epilation could result from androgen stimulated conversion of previously dormant vellus hairs, which are not affected by the laser as long as they remain dormant and unpigmented.
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Why are at least 3-6 treatment sessions usually needed?
All lasers work by disabling hairs that are in their active growth cycle at the time of treatment. Hair follicles in their “dormant” phase have no hair shaft in them and so will not be affected by the laser. Because hair follicles cycle through “active” and “dormant” phases, additional sessions are usually desired once the “dormant” follicles become “active”, and also to deal with hair follicles which were stunned but not killed by previous treatment. The other group of hair follicles which could produce dark terminal hair in the future are the fine vellus “peach fuzz” follicles which have no pigment and so are not affected by laser treatment. If some of these fine little “peach fuzz” follicles mature into terminal hair follicles, they can be treated with laser at that time.
There is NO treatment which will kill 100% of the hair follicles, 100% of the time. Laser hair removal is not an exact science because there are so many variables. Your laser technician can discuss “averages” and give you an estimate of the number of treatments based on past experience.
At any one time, 50 to 85% of your hair follicles are in the active (anagen) phase but only 1/4 to 1/3 of your hairs have enough of the pigment in their ROOTS to absorb the laser beam which destroys the hair root. So, about 1/4 to 1/3 (25% to 33%) of your hair roots are good targets for the laser beam, and can be damaged or destroyed in a single laser session.
Because 1/4 to 1/3 of the actively growing pigmented hair roots are damaged or destroyed in any one session, almost all people will want a minimum of three to four treatments to reach a satisfactory degree of hair reduction, and many people will wish to have more than four treatments, most commonly 5 to 8 treatments; and in some cases another session in six to twelve months to eliminate any terminal hairs which have developed when vellus hair follicles mature into terminal hair follicles.
The number of treatments depends on:
the desired degree of hair reduction (as the amount of hair declines, some people become very enthusiastic and want even LESS hair than they had originally planned).
hair color (people with naturally light colored hair need more treatments)
ethnic and genetic background (people with dark skin sometimes need more treatments).
hormonal status
area being treated
hair density
age
weight (obesity can increase hair growth)
medication (for example medicines like Dilantin and cyclosporine can increase hair growth)
Additional “touchup” treatments on small troublesome areas are treated at reduced rates There is no safety limit on the number of treatments a person can have. People who have been partially treated with other types of hair removing laser might in some cases need less than 3 laser treatments to reach a satisfactory degree of long-term hair reduction.
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Previous laser treatment or electrolysis? No problem!
Candela GentleLASE has been successfully used on many people who were not able to tolerate - or did not obtain satisfactory results with electrolysis, or with older laser and "high intensity light" systems, including ruby laser, and Epilight™ systems.
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Am I a good candidate for laser hair removal?
The unique design of the Candela GentleYag allows treatment of people with most skin colors up to and including African American skin types and people with tanned skin. Because hair which is naturally blonde, light red or white does not have enough pigment in the roots, it cannot be reliably treated with any type of laser. Children can be treated, for example if they have a congenital nevus or other problem with excessive hair, but the children must be old enough (for example, 12 years old) to understand and cooperate with treatment. We frequently treat young, preteen girls who have develolped dark hair on the upper lips.
Laser hair removal is not just for “cosmetic” problems. Patients with excess hair because of medications (i.e., organ transplant patients who are taking cyclosporine) can benefit from laser hair removal; as can patients who have problems with ingrown hair and folliculitis under prosthetic devices.
Many people at some time before laser hair removal have fears and doubts. A common concern is that they are being vain. Most patients who have laser hair removal are no more vain than anyone else. What does distinguish them is a desire to get the most out of life. Looking after our appearance is not a fault. After all would you leave your house with broken gutters or peeling paint? Why do less for your body? You should feel proud of yourself for having the courage to want to change something that you find unacceptable. Normal, reasonable people who have realistic expectations tend to be excellent candidates for laser hair removal treatments.
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Which hair colors respond best to treatment?
Because lasers target the PIGMENT in hair roots, lasers work best on black or brown hair. Light brown or auburn hair may require more treatment sessions. White hair does not respond to treatment — so get your hair removed before you get old and your hair turns white!
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Questions to ask yourself when considering laser hair reduction:
How much are you bothered by your facial hair? Hair on other areas?
How much are you bothered by the time you spend removing, treating, or concealing your facial hair? Hair on other areas?
How uncomfortable does your facial or other unwanted hair make you feel in exchanges of affection (such as intimate exchanges with your partner)?
How uncomfortable does your unwanted hair make you feel when you meet new people?
How uncomfortable does your unwanted hair make you feel when you go to social gatherings, dine out in a public restaurant, go to a supermarket or other public place?
How uncomfortable does your unwanted hair make you feel when you go to work or class?
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What are Hirsutism and Hypertrichosis?
Hirsutism is excessive growth of hair in androgen (testosterone) -dependent areas of a woman’s body where terminal hair is not normally found, including the face, neck, chest or medial thighs.
Hypertrichosis is excessive growth of hair in non-androgen dependent parts of the body (i.e.. Areas other than the face, neck, chest and medial thighs).
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What is Unwanted Female Facial Hair?
Growth of hair on the face which is coarser, longer or more profuse than is “normal” for the age and race of the woman. Unwanted Facial Hair is a chronic problem for about 22 million American women who remove facial hair at least once a week.
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How can I get the best value from each treatment?
To get the best results with the smallest number of treatment sessions, please pay attention to the following guidelines as you work with us:
A. Avoid waxing / sugaring / plucking / EpiLady and electrolysis
Because the laser beam seeks out and destroys ACTIVELY GROWING hair roots, it is important (if you want to get the best value from your treatment) NOT to wax / pluck / sugar / use EpiLady-type pluckers or have electrolysis for at least two weeks before laser treatment. These things temporarily remove the pigmented part of the hair follicle which the laser needs to use as a target when it destroys the hair follicle.
B. Please avoid tanning!
The Candela GentleYag is safe and effective laser for most types of skin. Many Italian, Greek, and East Asian have been successfully treated with the Candela GentleYag laser. BUT: the lighter your skin color at the time of treatment, the better the laser beam can get through the skin to the hair roots, where it is needed. If you avoid tanning and stop using artificial “tanning” creams for six weeks before treatment, you will get the maximum possible benefit from each treatment session. People with very darker skin should also take precautions in the sun and wear a sunscreen between sessions.
It is also a good idea to minimize tanning for a few weeks after laser treatment, to reduce the chance that your tan will be somewhat uneven. Protect yourself by using a sunscreen on all treated areas before, during and after treatments.
C. Shaving or clipping the hair? Good idea!
Shaving or clipping the area to be treated is not a problem. In fact, we like the areas to be shaved the day of treatment or the day before. Some people find that the skin is less sensitive if it is shaved at least a few hours before treatment. Another advantage of shaving the area to be treated BEFORE you come in is that YOU can shape the area to be treated exactly the way YOU want it to be. This is of particular importance in areas like the sideburns, temples, and bikini line / bikini area.
Excess hair must be removed from the treatment area before treatment, because hair ABOVE the surface of the skin will simply absorb and waste laser energy and keep it from getting to the hair roots, where it is needed. If you do not wish to shave the area, our technicians will do it for you.
Contrary to popular belief, shaving DOES NOT make hair grow back thicker, faster, darker or more profusely! So go ahead and shave before treatment, and between treatments!
D. Bleaching? No problem!
Because the laser beam only acts on the hair ROOTS, it is OK to bleach hair in the areas to be treated because bleaching will not affect the color of the roots. We do prefer that you stop bleaching before your first visit so that we can see the hair to be treated and give you an accurate evaluation.
E. Timing
It takes 4 to 8 weeks for the next crop of hair roots to become active and develop pigment which is the target for the laser. So, to get the best value from your treatments, you treatments will be scheduled at 4-8 weeks intervals. There is no harm in having treatments MORE FREQUENTLY than every 4-8 weeks, or having treatments less than 4 weeks after waxing, plucking, etc. — but this is less efficient, and could increase the total number of treatments needed to get a good result. Also, while there is no harm in waiting MORE THAN 4-8 weeks between treatments (for example, if there has not been much regrowth after your last treatment), there is usually no extra BENEFIT to waiting longer than 6-12 weeks between treatments.
F. Medications?
There are a few medications which should not be taken while you are getting laser treatment. Anabolic steroids should certainly NOT be taken unless medically necessary, because these can increase male-pattern hair growth in some cases. We cannot treat you if you are presently or have recently used Accutane or Bactrim. Women who take injections of Climacteron (testosterone & estradiol) as part of therapy for menopause and to increase libido often experience unwanted hair growth, which can be treated with laser hair removal.
Medicines which inhibit hair growth (for example, spironolactone, Diane-35 birth control pills, Euflex, Androcur and Vaniqa cream) might slightly reduce the pigment in hair roots and make laser treatment less efficient, but this seldom interferes with the effectiveness of laser treatment. Laser hair removal can certainly be done WHILE you are on those medicines, if you wish. These “anti-androgenic” medicines produce gradual but temporary effects, and will not remove unwanted hair from areas that are independent of androgen regulation.
Pretreatment with medicines like Acyclovir, Valtrex or Famvir may be necessary if you tend to get cold sores in the area to be treated.
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What is a “test area”, and why is it performed?
Test areas” are small areas of skin that are treated at various laser energy levels prior to treatment. “Test areas” are to determine the level of energy that is best for that individual. On darker skin types, these tests are reviewed one week later to make sure there was no burning or pigment change. Light skin types generally do not have to have wait because test results are fairly rapid. This may be done at the same time as your consultation.
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Moles, freckles and tattoos in the area to be treated?
Small moles and freckles do not require special precautions. Large, dark moles and freckles which are to be treated will require a reduction in the intensity of the laser light, the same way that the intensity would be reduced when treating a dark-skinned or tanned person. We do not treat tattoos, but this is seldom a problem because quite often there is not much hair growth in tattoos. Be sure to tell us if you have permanent lip liner or permanent eyebrows, because these are tattoos and special precautions are needed if there will be laser treatment near those areas.
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What will happen on the treatment day?
HELLO LASER, GOOD-BYE RAZOR!
Lasting hair removal has never been this easy! Other than your regular skin care routine, there is no standard “prep” for this procedure. Please do not wear makeup on the areas to be treated, because some kinds of makeup can absorb and waste laser energy, or even heat up to the point where your skin would be irritated. Makeup will need to be removed before treatment, and may be reapplied after two hours. Do not apply vaseline, lip balm or other heavy petroleum based products on the area to be treated. There are no restrictions on what you may eat or drink prior to your appointment.
Please do not shave the area to be treated on the day of your treatment. We like to see a small amount of hair to determine regrowth patterns.
After all of your last minute questions have been answered and paperwork handled, the areas you wish to have treated will be cleansed and pretreatment photos may be taken. Everyone in the treatment room must wear protective goggles when the laser is turned on. The Candela GentleYag is a high powered laser system, and can cause eye injury if proper eye wear is not worn.
The length of the procedure itself can range from a few minutes for the upper lip to an hour or more (for example, a man’s chest or back).
If you decide before coming in that you would like to have additional areas treated, please call ahead so that we can schedule enough time to accommodate your needs.
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Does it hurt?
The laser emits only light. You may feel a tingling or snapping sensation like a rubber band. There is no bleeding and no open wound is created. Some people find the FIRST laser treatment more uncomfortable than subsequent treatments. This is because there are more hair roots which are destroyed during the first treatment; and perhaps also because some people are more apprehensive during the first treatment, because they are not sure of what to expect.
While some areas of the body like the upper lip and pubic hair area are more sensitive than others, many patients report little or no discomfort. Your technician is well-trained in discomfort management techniques and will prepare your treatment accordingly. If you are scheduled to have topical anesthetic applied, ample time will be allowed. People who have had waxing, sugaring, and/or electrolysis (or treatment with other lasers) usually report that Candela GentleYag causes less discomfort, and sometimes there is almost no discomfort.
The Candela GentleYag features the Dynamic Cooling Device (DCD). This device sprays a short burst of cryogen to the skin a split second prior to pulsing. This coolant protects the skin and makes the treatment more comfortable for you. The cooling spray can be adjusted to suit your skin type and hair type and is computer calibrated for carefully controlled delivery.
We use a prescription strength topical anesthetic gel in very sensitive areas or by those who think they have a very low pain threshold. A decision to use topical is determined at your initial consultation visit. Some people find it helpful to take two or three plain Tylenol and/or Advil a couple of hours before coming in for treatment. Some women find that they are more sensitive during their menstrual cycles, however, this would not preclude treatment.
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What will happen after treatment?
Generalized redness and edema are quite common after treatment. These symptoms usually subside within an hour or so. Some patients report redness lasting for up to 48 hours which is still within acceptable norms. In most cases, redness has faded greatly by the time you get home. It would not be uncommon for the skin to be slightly drier that evening. Premiere recommends using Aloe Vera and Dr. Berman’s moisturizer. Your technician will give you small jars of aftercare products to use that evening. There are no limitations to your activities, however, we ask that you do not take a hot shower or bath for the first day. We will ask you not to workout or engage in any physical activity that may cause sweating for the first 24 hours. Our experience has shown that better results are achieved with less irritation when you do not reheat the skin with hot water or exercise.
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Why does the hair sometimes look like it’s “growing” for 1-3 weeks after laser treatment?
Lasers destroy hair roots which are active at the time of treatment, but do not remove hair shafts instantly. Hair shafts in the treated hair follicles will fall out, or be “shed” mostly in the first week after treatment, with all of the treated hairs falling out within 2-3 weeks. It is normal that some hairs in the treated area may not fall out within 2-3 weeks. These will treated in the next session.
These hairs which are being shed will come out on their own. It is best not to shave the treated area. If the skin is irritated, use only soft wash clothes and mild soap and moisturizing creams. You may use exfoliating gloves in the treated area but it is not really necessary.
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Are there any restrictions on my activity after treatment?
Since the laser does not burn or cut the skin in any way, no bandages are necessary. You can return to work the same day and resume all your regular activities. Please do not tan the skin or use tanning creams between treatments. Tanning between treatments can increase the risk of hyperpigmentation and uneven skin coloration. It is OK to resume shaving or clipping hair in the treated area after 3-4 days. Do not tweeze, wax or sugar the hair between treatments. In the bikini area, it is best not to shave at all between treatments to avoid ingrown hair problems.
Shaving really is the BEST temporary way to remove unwanted hair before and between laser treatments. Shaving leaves the hair SHAFT in the hair follicle, so the hair shaft can be a target for laser energy, heat up and KILL the hair follicle.
You can shave as often as you want. It has been shown in scientific studies that:
Shaving does NOT make hair grow faster.
Shaving does NOT make hair grow thicker.
Shaving does NOT make hair grow darker.
Shaving does NOT make hair grow more profusely.
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Pre-treatment instructions:
Please do not wax or tweeze the hair for 2-3 weeks before treatment, because hair follicles which do not have hair shafts in them to absorb laser energy will not be killed by the laser energy.
Please stop tanning immediately. A fresh tan can interfere with the effectiveness of the treatment and possibly even cause complications. Tell is if you have tanned recently. We cannot treat you if you have been tanning within the ten day period before your treatment.
You may shave or clip the areas to be treated the day before treatment or on the morning of treatment. Shaving before you come in also allows you to shape the exact area you want treated — this is sometimes very useful in areas like the hairline and sideburns, and in the bikini area. Excess hair above the surface of the skin absorbs and wastes laser energy, and reduces the amount of energy that reaches the hair root, where it is really needed. Excess hair above the surface of the skin also increases the chance of burning or irritating the skin.
Some people find it helpful to simply take 2 or 3 Tylenol and/or Advil 2 hours before coming in for treatment. Some women who find that they are less sensitive after their menses prefer to schedule their treatment sessions to avoid the premenstrual and menstrual time. During the treatment, remember that we care about your comfort. Unexpected discomfort is nature’s way of telling us something is wrong, so please tell us and we will go slower, apply more cooling, or adjust the power of the laser for you.
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Pre-treatment instructions:
Redness often has faded greatly by the time you get home. It would not be uncommon for the skin to be slightly drier that evening and to require more of your favorite moisturizer. We recommend Dr. Andrew Berman’s Aboriginal Gold which can be purchased at the center. The hair follicles may appear slightly more obvious or a bit pink for the next day or two, but this is seldom a cosmetic problem, and generally much less obvious than after waxing shaving.
Do not tan or use tanning creams between treatments. If you must be in the sun, please wear a sunscreen of 30 SPF or higher and apply it frequently if you are swimming or perspiring.
Hair shafts will be released from hair follicles in the treated area for a week or two after treatment. You do not need to do anything, but you may gently exfoliate or shave the areas if you wish.
Shaving, is OK between laser treatments. Tweezing, waxing and sugaring should be avoided because these things could reduce the effectiveness of your next laser treatment.
Blistering or scaling after GentleYag laser hair removal is very uncommon, but usually resolves over a few days or a week with a bit of Polysporin cream several times a day. Please call us if this happens, or if you have any other problems or questions.
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How do I get started?
Consultations can be arranged within a week simply by calling us at metro (940) 320-5432. Treatment can scheduled within a few days of consultation. Our technicians will take the time to discuss your wishes and options, and answer your questions.
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Laser Hair Removal
Imagine having smooth, hair free skin without shaving, waxing, plucking, or bleaching your unwanted hair. We now offer safe, fast, effective, and affordable Laser Hair Removal Services. Visit our laser hair removal section and discover the Premiere Laser Centre difference.
Laser hair removal: Zapping unwanted hair
Medical lasers have been used for dermatology applications such as removal of port wine stains, dark spots, tattoos, acne scars and other blemishes for over a decade. Lasers are used for a growing number of cosmetic procedures including hair removal, treatment of wrinkles, and tooth whitening. For risk information on the specific laser treatment that you are considering, ask your physician or operator for the patient labeling for the laser device.
HAIR REMOVAL
The popularity of laser hair removal has increasingly grown, prompting many laser manufacturers to conduct research and seek FDA clearance for their lasers for this indication. The market is growing so quickly that FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal, as this list continues to change. To learn if a specific manufacturer has received FDA clearance, you can check FDA's Website at http://www.fda.gov/cdrh/databases.html under the 510(k) database. You will need to know the manufacturer or device name of the laser. You can also call FDA's Center for Devices and Radiological Health, Consumer Staff, at 1-888-INFO-FDA or 301-827-3990, fax your request to 301-443-9535 or send an e-mail to: DSMICA@cdrh.fda.gov.
Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure. Further, manufacturers may not claim that laser hair removal is either painless or permanent unless the FDA determines that there are sufficient data to demonstrate such results. Several manufacturers received FDA permission to claim, "permanent reduction," NOT "permanent removal" for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair. The specific claim granted is "intended to effect stable, long-term, or permanent reduction" through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions. The number of hairs regrowing must be stable over time greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area.
FDA does not make comparisons between systems or how well or safely they work compared to another company's system. FDA does not recommend one laser system over another.
Lasers cleared for body hair removal are also cleared for facial hair removal.
WRINKLE TREATMENT
Lasers are also being used to treat wrinkles. Several manufacturers have received FDA clearance to claim treatment of wrinkles, while others may claim skin resurfacing. Patients have reported reddening of the skin, which lasted from one to four months. Pain was mild and could be treated with over-the-counter analgesics. Consumers should bear in mind that skin abrasion, whether achieved by lasers, chemicals or abrasive materials, means removing one or more layers of skin, which can be painful and could cause redness, swelling or scarring, depending on how each person heals.
People considering this procedure should consult a dermatologist or the manufacturer to determine whether or not they would be good candidates. Be sure to ask your dermatologist for a copy of the patient labeling for the specific laser device used to understand the risks.
DENTAL TREATMENTS
Several manufacturers have received clearance for argon and carbon dioxide lasers to activate tooth-bleaching solutions and to treat gum disease. Several lasers have clearance for hard tissue use on teeth. On May 7, 1997 FDA cleared the first laser system for treating tooth decay, an erbium YAG laser made by Premier Laser Systems. Recently, American Dental Technologies received FDA clearance to market its laser for caries removal; it is not cleared to remove tooth enamel.
Studies conducted by the manufacturers showed that the laser is as safe and effective as a high-speed drill for removing dental decay and preparing a cavity for a filling. The manufacturer's study indicated that fewer patients needed anesthetic for pain. Any inquiries regarding this method of cavity treatment should be directed to your dentist, who can provide you with patient labeling including risks for the specific laser.
EYE SURGERY
Lasers may be used to remove tissue in eye surgery as well. This may include removing tumors, cataracts, or proliferating blood vessels common to diabetic retinopathy. Several manufacturers have lasers cleared for photorefractive keratectomy (PRK) and Laser-Assisted In Situ Keratomileusis (LASIK), two procedures for correcting nearsightedness, farsightedness, and astigmatism. The laser is used to reshape the cornea and focus images correctly on the retina. For information on eye surgery and which lasers have received clearance, you can access FDA's Website at: http://www.fda.gov/cdrh/LASIK. As with the other types of patient labeling, be sure to ask the surgeon for the patient labeling for the specific laser device being used.
OTHER MEDICAL USES
Some lasers have been cleared for medical uses such as removing tissue. Because heat from lasers cauterizes blood vessels, there is less bleeding compared to scalpel use. Usually, FDA gives manufacturers general surgical clearances; in order to promote the laser for a specific surgical procedure, manufacturers must first provide FDA with clinical evidence that their lasers are safe and effective for that specific procedure. If you wish to learn whether a specific laser has been cleared for a specific indication, you may contact FDA's Consumer Staff. You will need to provide the name of the manufacturer and the specific product name of the device before contacting the Consumer Staff.
PRACTITIONERS
States regulate who can use lasers for various therapeutic procedures. Medical lasers are prescription devices available for sale only to licensed practitioners. You should check with your state medical licensing board to determine who qualifies as a licensed practitioner in your state.
BIOSTIMULATION LASERS
Biostimulation lasers, also called low level laser therapy (LLLT), cold lasers, soft lasers, or laser acupuncture devices, were cleared for marketing by FDA through the Premarket Notification/510(k) process as adjunctive devices for the temporary relief of pain. These clearances were based on the presentation of clinical data to support such claims. FDA will consider similar applications for these and other claims with the decision to require clinical data being made on an individual basis, taking into consideration both the device and the claim. Please note that FDA law and regulations contain provisions that permit limited distribution of unapproved devices for use in clinical investigations. There are numerous clinical investigations being conducted in this and other countries to determine safety and efficacy with these devices for the intended uses that are proposed.
Biostimulation lasers are non-significant risk Class II medical devices and may be distributed in the U.S. to individual practitioners who have approval from an Institutional Review Board (IRB) for the investigational clinical use of the device. Even with IRB approval, a sponsor must comply with the Investigational Device Exemption (IDE) requirements such as monitoring investigations, maintaining records, making reports, and complying with prohibitions on promotion and commercialization of investigational devices. The investigators would have similar responsibilities, also covered in 21 CFR 812.
LASER RADIATION SAFETY
All laser devices distributed for both human and animal treatment in the U.S. are subject to Mandatory Performance Standards. They must meet the Federal laser product performance standard and must submit an "initial report" to CDRH's Office of Compliance prior to distributing the product (see 21 CFR 1000-1040.11). This performance standard specifies the safety features and labeling that all laser products must have in order to provide adequate safety to users and patients. A laser product manufacturer must certify that each model complies with the standard before introducing the laser into U.S. commerce. This includes distribution for use during clinical investigations prior to device approval.
Certification of a laser product means that each unit has passed a quality assurance test and that it complies with the performance standard. The firm that certifies a laser product assumes responsibility for product reporting, recordkeeping, and notification of defects, noncompliances, and accidental radiation occurrences, as specified in sections 21 CFR 1000-1010. A certifier of a laser product is required to report the product via a Laser Product Report submitted to CDRH. Reporting guides and related regulatory information are available from the DSMA web site at: http://www.fda.gov/cdrh/devadvice. Distribution of any certified laser products internationally would also require submission of the report.
HAIR REMOVAL
The popularity of laser hair removal has increasingly grown, prompting many laser manufacturers to conduct research and seek FDA clearance for their lasers for this indication. The market is growing so quickly that FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal, as this list continues to change. To learn if a specific manufacturer has received FDA clearance, you can check FDA's Website at http://www.fda.gov/cdrh/databases.html under the 510(k) database. You will need to know the manufacturer or device name of the laser. You can also call FDA's Center for Devices and Radiological Health, Consumer Staff, at 1-888-INFO-FDA or 301-827-3990, fax your request to 301-443-9535 or send an e-mail to: DSMICA@cdrh.fda.gov.
Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure. Further, manufacturers may not claim that laser hair removal is either painless or permanent unless the FDA determines that there are sufficient data to demonstrate such results. Several manufacturers received FDA permission to claim, "permanent reduction," NOT "permanent removal" for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair. The specific claim granted is "intended to effect stable, long-term, or permanent reduction" through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions. The number of hairs regrowing must be stable over time greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area.
FDA does not make comparisons between systems or how well or safely they work compared to another company's system. FDA does not recommend one laser system over another.
Lasers cleared for body hair removal are also cleared for facial hair removal.
WRINKLE TREATMENT
Lasers are also being used to treat wrinkles. Several manufacturers have received FDA clearance to claim treatment of wrinkles, while others may claim skin resurfacing. Patients have reported reddening of the skin, which lasted from one to four months. Pain was mild and could be treated with over-the-counter analgesics. Consumers should bear in mind that skin abrasion, whether achieved by lasers, chemicals or abrasive materials, means removing one or more layers of skin, which can be painful and could cause redness, swelling or scarring, depending on how each person heals.
People considering this procedure should consult a dermatologist or the manufacturer to determine whether or not they would be good candidates. Be sure to ask your dermatologist for a copy of the patient labeling for the specific laser device used to understand the risks.
DENTAL TREATMENTS
Several manufacturers have received clearance for argon and carbon dioxide lasers to activate tooth-bleaching solutions and to treat gum disease. Several lasers have clearance for hard tissue use on teeth. On May 7, 1997 FDA cleared the first laser system for treating tooth decay, an erbium YAG laser made by Premier Laser Systems. Recently, American Dental Technologies received FDA clearance to market its laser for caries removal; it is not cleared to remove tooth enamel.
Studies conducted by the manufacturers showed that the laser is as safe and effective as a high-speed drill for removing dental decay and preparing a cavity for a filling. The manufacturer's study indicated that fewer patients needed anesthetic for pain. Any inquiries regarding this method of cavity treatment should be directed to your dentist, who can provide you with patient labeling including risks for the specific laser.
EYE SURGERY
Lasers may be used to remove tissue in eye surgery as well. This may include removing tumors, cataracts, or proliferating blood vessels common to diabetic retinopathy. Several manufacturers have lasers cleared for photorefractive keratectomy (PRK) and Laser-Assisted In Situ Keratomileusis (LASIK), two procedures for correcting nearsightedness, farsightedness, and astigmatism. The laser is used to reshape the cornea and focus images correctly on the retina. For information on eye surgery and which lasers have received clearance, you can access FDA's Website at: http://www.fda.gov/cdrh/LASIK. As with the other types of patient labeling, be sure to ask the surgeon for the patient labeling for the specific laser device being used.
OTHER MEDICAL USES
Some lasers have been cleared for medical uses such as removing tissue. Because heat from lasers cauterizes blood vessels, there is less bleeding compared to scalpel use. Usually, FDA gives manufacturers general surgical clearances; in order to promote the laser for a specific surgical procedure, manufacturers must first provide FDA with clinical evidence that their lasers are safe and effective for that specific procedure. If you wish to learn whether a specific laser has been cleared for a specific indication, you may contact FDA's Consumer Staff. You will need to provide the name of the manufacturer and the specific product name of the device before contacting the Consumer Staff.
PRACTITIONERS
States regulate who can use lasers for various therapeutic procedures. Medical lasers are prescription devices available for sale only to licensed practitioners. You should check with your state medical licensing board to determine who qualifies as a licensed practitioner in your state.
BIOSTIMULATION LASERS
Biostimulation lasers, also called low level laser therapy (LLLT), cold lasers, soft lasers, or laser acupuncture devices, were cleared for marketing by FDA through the Premarket Notification/510(k) process as adjunctive devices for the temporary relief of pain. These clearances were based on the presentation of clinical data to support such claims. FDA will consider similar applications for these and other claims with the decision to require clinical data being made on an individual basis, taking into consideration both the device and the claim. Please note that FDA law and regulations contain provisions that permit limited distribution of unapproved devices for use in clinical investigations. There are numerous clinical investigations being conducted in this and other countries to determine safety and efficacy with these devices for the intended uses that are proposed.
Biostimulation lasers are non-significant risk Class II medical devices and may be distributed in the U.S. to individual practitioners who have approval from an Institutional Review Board (IRB) for the investigational clinical use of the device. Even with IRB approval, a sponsor must comply with the Investigational Device Exemption (IDE) requirements such as monitoring investigations, maintaining records, making reports, and complying with prohibitions on promotion and commercialization of investigational devices. The investigators would have similar responsibilities, also covered in 21 CFR 812.
LASER RADIATION SAFETY
All laser devices distributed for both human and animal treatment in the U.S. are subject to Mandatory Performance Standards. They must meet the Federal laser product performance standard and must submit an "initial report" to CDRH's Office of Compliance prior to distributing the product (see 21 CFR 1000-1040.11). This performance standard specifies the safety features and labeling that all laser products must have in order to provide adequate safety to users and patients. A laser product manufacturer must certify that each model complies with the standard before introducing the laser into U.S. commerce. This includes distribution for use during clinical investigations prior to device approval.
Certification of a laser product means that each unit has passed a quality assurance test and that it complies with the performance standard. The firm that certifies a laser product assumes responsibility for product reporting, recordkeeping, and notification of defects, noncompliances, and accidental radiation occurrences, as specified in sections 21 CFR 1000-1010. A certifier of a laser product is required to report the product via a Laser Product Report submitted to CDRH. Reporting guides and related regulatory information are available from the DSMA web site at: http://www.fda.gov/cdrh/devadvice. Distribution of any certified laser products internationally would also require submission of the report.
Laser hair removal: Zapping unwanted hair
Medical lasers have been used for dermatology applications such as removal of port wine stains, dark spots, tattoos, acne scars and other blemishes for over a decade. Lasers are used for a growing number of cosmetic procedures including hair removal, treatment of wrinkles, and tooth whitening. For risk information on the specific laser treatment that you are considering, ask your physician or operator for the patient labeling for the laser device.
HAIR REMOVAL
The popularity of laser hair removal has increasingly grown, prompting many laser manufacturers to conduct research and seek FDA clearance for their lasers for this indication. The market is growing so quickly that FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal, as this list continues to change. To learn if a specific manufacturer has received FDA clearance, you can check FDA's Website at http://www.fda.gov/cdrh/databases.html under the 510(k) database. You will need to know the manufacturer or device name of the laser. You can also call FDA's Center for Devices and Radiological Health, Consumer Staff, at 1-888-INFO-FDA or 301-827-3990, fax your request to 301-443-9535 or send an e-mail to: DSMICA@cdrh.fda.gov.
Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure. Further, manufacturers may not claim that laser hair removal is either painless or permanent unless the FDA determines that there are sufficient data to demonstrate such results. Several manufacturers received FDA permission to claim, "permanent reduction," NOT "permanent removal" for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair. The specific claim granted is "intended to effect stable, long-term, or permanent reduction" through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions. The number of hairs regrowing must be stable over time greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area.
FDA does not make comparisons between systems or how well or safely they work compared to another company's system. FDA does not recommend one laser system over another.
Lasers cleared for body hair removal are also cleared for facial hair removal.
WRINKLE TREATMENT
Lasers are also being used to treat wrinkles. Several manufacturers have received FDA clearance to claim treatment of wrinkles, while others may claim skin resurfacing. Patients have reported reddening of the skin, which lasted from one to four months. Pain was mild and could be treated with over-the-counter analgesics. Consumers should bear in mind that skin abrasion, whether achieved by lasers, chemicals or abrasive materials, means removing one or more layers of skin, which can be painful and could cause redness, swelling or scarring, depending on how each person heals.
People considering this procedure should consult a dermatologist or the manufacturer to determine whether or not they would be good candidates. Be sure to ask your dermatologist for a copy of the patient labeling for the specific laser device used to understand the risks.
DENTAL TREATMENTS
Several manufacturers have received clearance for argon and carbon dioxide lasers to activate tooth-bleaching solutions and to treat gum disease. Several lasers have clearance for hard tissue use on teeth. On May 7, 1997 FDA cleared the first laser system for treating tooth decay, an erbium YAG laser made by Premier Laser Systems. Recently, American Dental Technologies received FDA clearance to market its laser for caries removal; it is not cleared to remove tooth enamel.
Studies conducted by the manufacturers showed that the laser is as safe and effective as a high-speed drill for removing dental decay and preparing a cavity for a filling. The manufacturer's study indicated that fewer patients needed anesthetic for pain. Any inquiries regarding this method of cavity treatment should be directed to your dentist, who can provide you with patient labeling including risks for the specific laser.
EYE SURGERY
Lasers may be used to remove tissue in eye surgery as well. This may include removing tumors, cataracts, or proliferating blood vessels common to diabetic retinopathy. Several manufacturers have lasers cleared for photorefractive keratectomy (PRK) and Laser-Assisted In Situ Keratomileusis (LASIK), two procedures for correcting nearsightedness, farsightedness, and astigmatism. The laser is used to reshape the cornea and focus images correctly on the retina. For information on eye surgery and which lasers have received clearance, you can access FDA's Website at: http://www.fda.gov/cdrh/LASIK. As with the other types of patient labeling, be sure to ask the surgeon for the patient labeling for the specific laser device being used.
OTHER MEDICAL USES
Some lasers have been cleared for medical uses such as removing tissue. Because heat from lasers cauterizes blood vessels, there is less bleeding compared to scalpel use. Usually, FDA gives manufacturers general surgical clearances; in order to promote the laser for a specific surgical procedure, manufacturers must first provide FDA with clinical evidence that their lasers are safe and effective for that specific procedure. If you wish to learn whether a specific laser has been cleared for a specific indication, you may contact FDA's Consumer Staff. You will need to provide the name of the manufacturer and the specific product name of the device before contacting the Consumer Staff.
PRACTITIONERS
States regulate who can use lasers for various therapeutic procedures. Medical lasers are prescription devices available for sale only to licensed practitioners. You should check with your state medical licensing board to determine who qualifies as a licensed practitioner in your state.
BIOSTIMULATION LASERS
Biostimulation lasers, also called low level laser therapy (LLLT), cold lasers, soft lasers, or laser acupuncture devices, were cleared for marketing by FDA through the Premarket Notification/510(k) process as adjunctive devices for the temporary relief of pain. These clearances were based on the presentation of clinical data to support such claims. FDA will consider similar applications for these and other claims with the decision to require clinical data being made on an individual basis, taking into consideration both the device and the claim. Please note that FDA law and regulations contain provisions that permit limited distribution of unapproved devices for use in clinical investigations. There are numerous clinical investigations being conducted in this and other countries to determine safety and efficacy with these devices for the intended uses that are proposed.
Biostimulation lasers are non-significant risk Class II medical devices and may be distributed in the U.S. to individual practitioners who have approval from an Institutional Review Board (IRB) for the investigational clinical use of the device. Even with IRB approval, a sponsor must comply with the Investigational Device Exemption (IDE) requirements such as monitoring investigations, maintaining records, making reports, and complying with prohibitions on promotion and commercialization of investigational devices. The investigators would have similar responsibilities, also covered in 21 CFR 812.
LASER RADIATION SAFETY
All laser devices distributed for both human and animal treatment in the U.S. are subject to Mandatory Performance Standards. They must meet the Federal laser product performance standard and must submit an "initial report" to CDRH's Office of Compliance prior to distributing the product (see 21 CFR 1000-1040.11). This performance standard specifies the safety features and labeling that all laser products must have in order to provide adequate safety to users and patients. A laser product manufacturer must certify that each model complies with the standard before introducing the laser into U.S. commerce. This includes distribution for use during clinical investigations prior to device approval.
Certification of a laser product means that each unit has passed a quality assurance test and that it complies with the performance standard. The firm that certifies a laser product assumes responsibility for product reporting, recordkeeping, and notification of defects, noncompliances, and accidental radiation occurrences, as specified in sections 21 CFR 1000-1010. A certifier of a laser product is required to report the product via a Laser Product Report submitted to CDRH. Reporting guides and related regulatory information are available from the DSMA web site at: http://www.fda.gov/cdrh/devadvice. Distribution of any certified laser products internationally would also require submission of the report.
HAIR REMOVAL
The popularity of laser hair removal has increasingly grown, prompting many laser manufacturers to conduct research and seek FDA clearance for their lasers for this indication. The market is growing so quickly that FDA cannot maintain an up-to-date list of all laser manufacturers whose devices have been cleared for hair removal, as this list continues to change. To learn if a specific manufacturer has received FDA clearance, you can check FDA's Website at http://www.fda.gov/cdrh/databases.html under the 510(k) database. You will need to know the manufacturer or device name of the laser. You can also call FDA's Center for Devices and Radiological Health, Consumer Staff, at 1-888-INFO-FDA or 301-827-3990, fax your request to 301-443-9535 or send an e-mail to: DSMICA@cdrh.fda.gov.
Manufacturers should be aware that receiving an FDA clearance for general permission to market their devices does not permit them to advertise the lasers for either hair removal or wrinkle treatment, even though hair removal or wrinkle treatment may be a by-product of any cleared laser procedure. Further, manufacturers may not claim that laser hair removal is either painless or permanent unless the FDA determines that there are sufficient data to demonstrate such results. Several manufacturers received FDA permission to claim, "permanent reduction," NOT "permanent removal" for their lasers. This means that although laser treatments with these devices will permanently reduce the total number of body hairs, they will not result in a permanent removal of all hair. The specific claim granted is "intended to effect stable, long-term, or permanent reduction" through selective targeting of melanin in hair follicles. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs re-growing after a treatment regime, which may include several sessions. The number of hairs regrowing must be stable over time greater than the duration of the complete growth cycle of hair follicles, which varies from four to twelve months according to body location. Permanent hair reduction does not necessarily imply the elimination of all hairs in the treatment area.
FDA does not make comparisons between systems or how well or safely they work compared to another company's system. FDA does not recommend one laser system over another.
Lasers cleared for body hair removal are also cleared for facial hair removal.
WRINKLE TREATMENT
Lasers are also being used to treat wrinkles. Several manufacturers have received FDA clearance to claim treatment of wrinkles, while others may claim skin resurfacing. Patients have reported reddening of the skin, which lasted from one to four months. Pain was mild and could be treated with over-the-counter analgesics. Consumers should bear in mind that skin abrasion, whether achieved by lasers, chemicals or abrasive materials, means removing one or more layers of skin, which can be painful and could cause redness, swelling or scarring, depending on how each person heals.
People considering this procedure should consult a dermatologist or the manufacturer to determine whether or not they would be good candidates. Be sure to ask your dermatologist for a copy of the patient labeling for the specific laser device used to understand the risks.
DENTAL TREATMENTS
Several manufacturers have received clearance for argon and carbon dioxide lasers to activate tooth-bleaching solutions and to treat gum disease. Several lasers have clearance for hard tissue use on teeth. On May 7, 1997 FDA cleared the first laser system for treating tooth decay, an erbium YAG laser made by Premier Laser Systems. Recently, American Dental Technologies received FDA clearance to market its laser for caries removal; it is not cleared to remove tooth enamel.
Studies conducted by the manufacturers showed that the laser is as safe and effective as a high-speed drill for removing dental decay and preparing a cavity for a filling. The manufacturer's study indicated that fewer patients needed anesthetic for pain. Any inquiries regarding this method of cavity treatment should be directed to your dentist, who can provide you with patient labeling including risks for the specific laser.
EYE SURGERY
Lasers may be used to remove tissue in eye surgery as well. This may include removing tumors, cataracts, or proliferating blood vessels common to diabetic retinopathy. Several manufacturers have lasers cleared for photorefractive keratectomy (PRK) and Laser-Assisted In Situ Keratomileusis (LASIK), two procedures for correcting nearsightedness, farsightedness, and astigmatism. The laser is used to reshape the cornea and focus images correctly on the retina. For information on eye surgery and which lasers have received clearance, you can access FDA's Website at: http://www.fda.gov/cdrh/LASIK. As with the other types of patient labeling, be sure to ask the surgeon for the patient labeling for the specific laser device being used.
OTHER MEDICAL USES
Some lasers have been cleared for medical uses such as removing tissue. Because heat from lasers cauterizes blood vessels, there is less bleeding compared to scalpel use. Usually, FDA gives manufacturers general surgical clearances; in order to promote the laser for a specific surgical procedure, manufacturers must first provide FDA with clinical evidence that their lasers are safe and effective for that specific procedure. If you wish to learn whether a specific laser has been cleared for a specific indication, you may contact FDA's Consumer Staff. You will need to provide the name of the manufacturer and the specific product name of the device before contacting the Consumer Staff.
PRACTITIONERS
States regulate who can use lasers for various therapeutic procedures. Medical lasers are prescription devices available for sale only to licensed practitioners. You should check with your state medical licensing board to determine who qualifies as a licensed practitioner in your state.
BIOSTIMULATION LASERS
Biostimulation lasers, also called low level laser therapy (LLLT), cold lasers, soft lasers, or laser acupuncture devices, were cleared for marketing by FDA through the Premarket Notification/510(k) process as adjunctive devices for the temporary relief of pain. These clearances were based on the presentation of clinical data to support such claims. FDA will consider similar applications for these and other claims with the decision to require clinical data being made on an individual basis, taking into consideration both the device and the claim. Please note that FDA law and regulations contain provisions that permit limited distribution of unapproved devices for use in clinical investigations. There are numerous clinical investigations being conducted in this and other countries to determine safety and efficacy with these devices for the intended uses that are proposed.
Biostimulation lasers are non-significant risk Class II medical devices and may be distributed in the U.S. to individual practitioners who have approval from an Institutional Review Board (IRB) for the investigational clinical use of the device. Even with IRB approval, a sponsor must comply with the Investigational Device Exemption (IDE) requirements such as monitoring investigations, maintaining records, making reports, and complying with prohibitions on promotion and commercialization of investigational devices. The investigators would have similar responsibilities, also covered in 21 CFR 812.
LASER RADIATION SAFETY
All laser devices distributed for both human and animal treatment in the U.S. are subject to Mandatory Performance Standards. They must meet the Federal laser product performance standard and must submit an "initial report" to CDRH's Office of Compliance prior to distributing the product (see 21 CFR 1000-1040.11). This performance standard specifies the safety features and labeling that all laser products must have in order to provide adequate safety to users and patients. A laser product manufacturer must certify that each model complies with the standard before introducing the laser into U.S. commerce. This includes distribution for use during clinical investigations prior to device approval.
Certification of a laser product means that each unit has passed a quality assurance test and that it complies with the performance standard. The firm that certifies a laser product assumes responsibility for product reporting, recordkeeping, and notification of defects, noncompliances, and accidental radiation occurrences, as specified in sections 21 CFR 1000-1010. A certifier of a laser product is required to report the product via a Laser Product Report submitted to CDRH. Reporting guides and related regulatory information are available from the DSMA web site at: http://www.fda.gov/cdrh/devadvice. Distribution of any certified laser products internationally would also require submission of the report.
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