FDA Clears Hair Reduction Device

Candela Corp. (Wayland, MA) said that its GentleLASE system has received FDA clearance to claim that it achieves "permanent hair reduction."

According to the FDA, permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing after a treatment regime. The GentleLASE demonstrated this capability in a long-term clinical study.

Jeffrey Dover, director of SkinCare Physicians of Chestnut Hill and Associate Clinical Professor of Dermatology at Harvard Medical School, said, "Candela's GentleLASE is safe, effective, and elegant in the treatment of unwanted hair. The recent FDA clearance for long-term hair reduction allows physicians to answer questions about long-term treatment results from today's very informed patients."

Candela's GentleLASE system was first introduced in 1997. It uses a proprietary Dynamic Cooling Device which selectively cools the upper layers of skin prior to applying the laser pulse, minimizing pain and reducing thermal exposure to the epidermis and upper layers of the skin.

Edited by Ursula Jones