Candela's GentleYAG Laser Receives FDA 510k Clearance for the Treatment of Pseudofolliculitis Barbae.

Business Editors/Health/Medical Writers

WAYLAND, Mass.--(BUSINESS WIRE)--Jan. 2, 2003

Candela Corporation (NASDAQ: CLZR) announced today that its GentleYAG(TM) Nd:YAG long pulse hair and vascular lesion laser has received 510(k) marketing clearance from the U.S. Food and Drug Administration (FDA) for the treatment of Pseudofolliculitis Barbae (PFB). PFB (also called razor or beard bumps) is a common skin condition around the bearded area of the face and neck of many men, with the highest incidence (at 60%) in African-Americans. PFB is caused when highly curved hairs grow back into the skin, causing inflammation due to the natural reaction to a foreign body.

Gerard E. Puorro, Candela's President and Chief Executive Officer, commented: "The FDA clearance for the GentleYAG underscores not only the efficacy of our hair removal lasers, but also their versatility. PFB is an increasingly common dermatological condition and the GentleYAG represents an ideal solution to the problem."

According to Elliot Lach, M.D, F.A.C.S., Director, Laser Surgery, University of Massachusetts Medical Center, Worcester, Massachusetts, the GentleYAG is ideal for treating dark skin types and PFB. "With GentleYAG, we need not be concerned over the type of laser for treating a particular skin type" said Lach. "We are able to focus solely on removing the hair itself and the GentleYAG is a good answer for short, wiry or thin hairs with a propensity to grow back onto itself and for those patients who are plagued by ingrown hairs."

The GentleYAG system was first introduced in April 2001 and has earned a reputation for safety, speed, efficacy and reliability. The GentleYAG offers a proprietary Dynamic Cooling Device(TM) (DCD) 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. The system has received wide acceptance among physicians including dermatologists, plastic surgeons, ENT (Ear, Nose and Throat) and OB/GYN Specialists, and other practitioners around the world.

About Candela: Candela Corporation develops, manufactures, and distributes innovative clinical solutions that enable physicians, surgeons, and personal care practitioners to treat selected cosmetic and medical conditions using lasers, aesthetic laser systems, and other advanced technologies. Founded near Boston in 1970, the company markets and services its products in over 60 countries from offices in the United States, Europe, Japan and Asia. Candela established the aesthetic laser market 13 years ago, and currently has an installed base of over 5,000 lasers worldwide. Candela is an Equal Opportunity and Affirmative Action Employer, M/F/H/V. Visit Candela on the Web at www.candelalaser.com.