Hair today, gone tomorrow - removing unwanted hair

FDA Consumer, Sept, 1996 by Marian Segal

Needle epilators are exempt from premarket notification; tweezers epilator manufacturers, however, must submit to FDA data showing their devices are substantially equivalent to similar devices already on the market. FDA is currently reviewing this policy.

"On Aug. 14, 1995, FDA published a Federal Register notice requesting manufacturers of tweezers epilators to submit safety and effectiveness data," Watson says. "After the information is analyzed, the agency will decide what kind of clearance will be required for these devices."

Laser

Hair removal entered the "laser age" last year when FDA cleared the ThermoLase Softlight laser, manufactured by Thermotrex Corporation, based in San Diego.

"The Softlight is essentially a standard dermatological laser similar to others already on the market for treating skin lesions and removing tattoos," says Richard Felten, a senior reviewer in FDA's Center for Devices and Radiological Health.

With the ThermoLase method, a proprietary topical black-colored solution is applied to the treatment area before the laser is scanned across it.

"The solution penetrates the hair follicles, and the black material in it preferentially absorbs the laser wavelength, which heats and destroys the follicles," Felten explains.

Three-month clinical trials of the ThermoLase process showed at least a 30 percent reduction of hair on treated areas in 60 to 70 percent of people treated. Manufacturers must limit claims of laser treatment permanence to results substantiated by the clinical data. Thermotrex, therefore, can claim that its laser process causes hair reduction for up to three months after treatment.

Some side effects can be expected whenever a laser is used to treat the skin, Felten says. These include redness, caused by heating the tissue; possibly some darkening of light-complexioned skin and lightening of dark-complexioned skin; and a risk of some scarring in some patients.

"Usually the treated area is covered to prevent infection during the healing period, and then kept covered with a moist solution for a period of time," Felten says, adding that sunlight should be avoided during healing also, to avoid a change in pigment.

A prescription device, the laser must be used under a licensed practitioner's direction. At press time, the Softlight laser was in use at several spas in San Diego and Dallas and in physicians' private practices, says ThermoLase's manager of Softlight, Rick Episcopo. Episcopo says clients may report a stinging in sensitive areas, such as the upper lip, but mostly a sensation of warmth.

Cosmetic hair removal can be quick and easy or time-consuming and somewhat uncomfortable. It can be costly or inexpensive. But, for just about anyone who so desires, there's a way to get rid of the hair you don't want.

Hair It Is

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