Syneron Candela wins FDA nod for Vbeam Prisma cosmetic laser

Syneron Candela said today it won FDA clearance for a next-gen version of its Vbeam, the Vbeam Prima cosmetic laser designed to treat skin conditions. The newly cleared device is intended for use in treating skin conditions including rosacea, port wine stains, acne, facial, leg and spider veins, scars, benign pigmented lesions and wrinkles, warts, stretch marks and photo aging, the Wayland, Mass.-based company said. “In a clinical study using Vbeam Prima, facial redness and rosacea symptoms were dramatically reduced after 4 treatments. I’ve worked with the Vbeam platform for years, and I am extremely excited about advancements with the Prima, especially the 50% greater power enabling a 15 mm spot size, both contact and spray cooling, once-a-day calibration and extended dye life thanks to a completely re-designed system,” Dr. Eric Bernstein of Ardmore, Penn.’s Main Line Center for Laser Surgery said in a prepared statement. The next-gen Vbeam Prima includes advanced features intended to improve results, simplify operation and improve the treatment experience, Candela said. “Building on the strong heritage of Vbeam, which has provided life changing aesthetic and dermatologic benefits for millions of patients for more than 20 years, the FDA clearance of the Vbeam Prima represents a step forward in the treatment of vascular and pigmented skin conditions. This important milestone exemplifies Candela’s mission of continuous innovation based on Â...
Source: Mass Device - Category: Medical Devices Authors: Tags: Cosmetic/Aesthetic Food & Drug Administration (FDA) Regulatory/Compliance Syneron Medical Ltd. Source Type: news