Cosmetic Laser Surgery Information

More plastic surgery information can be found at: Board Certified Plastic Surgeon

Are you considering having cosmetic laser surgery? Before you make that appointment with a board certified plastic surgeon, you might want to read the latest information from the FDA.gov web site.

We are not offering medical advice, nor are we associated with the FDA. We smply offer information to plastic surgery candidates on an "as is" basis. Please read our disclaimer and consult with your physician for more information.

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 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.

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. Above excerpt taken from FDA Update 5/17/2002 on Laser Surgery
Please visit FDA.gov to see if newer updates are available