Laser Facts

Laser and Other Forms of Hair Removal That Compete with Electrolysis*
By Dr. James Schuster

Laser hair removal has been in the spotlight for much of the last four years and continues into the year 2000. Despite the multi-million dollar attack on the hair follicle by well financed laser manufacturers, the tiny hair-producing marvel has been found to be quite resistant to all their noxious rays. Never before in history has so much money been pumped into the quest for hair destruction all because someone stated: “The hair removal industry is a multi-billion dollar business.” Currently there are alternate methods of hair removal competing with electrolysis for this billion dollar business. They are:

1. Laser Photoepilation
2. Non-laser Flashlamp Photoepilation
3. Microwave Epilation
4. Topical Methods e.g. (Eflomithine Cream – Vaniqa)

Limited data is available regarding microwave epilation and Eflomithine topical hair removal. We will report on these when more information is available. Currently laser and flashlamp photoepilation are being marketed as effective for permanent hair growth reduction with “reduction” being the key word. Unfortunately there have been no long term studies (greater than 1 year follow-up) with significant numbers of clients, published in peer reviewed medical journals to give us good data for comparison. Generally speaking, laser epilation is achieving only minimal permanence even under the best of conditions (fair skin and dark hair) and multiple treatments. We believe that electrolysis is still the gold standard for comparison when one is considering methods of permanent hair removal. Only electrolysis can remove any hair on any part of the body….
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*Excerpt from original article published April, 2000 for distribution by Prestige Electrolysis Supply, Inc.; excerpt at http://www.electrology.com/laserbyschuster.html

Laser Fact Sheet – May 2001*
FDA: Department of Health and Human Services
Center for Devices and Radiological Health

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.

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  or send an e-mail to: DSMA@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.

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.
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*The information above is an excerpt from the FDA’s May 2001 Laser Fact Sheet provided on the AEA’s website, and can be found in its entirety at http://www.fda.gov/cdrh/consumer/laserfacts.html