SEPTEMBER 17, 2008 -- Cosmetic laser device manufacturer Alma Lasers Ltd. (Caesarea, Israel and Buffalo Grove, IL) has received 510(k) clearance from the US Food and Drug Administration (FDA) for Pixel CO2, its just-launched fractional, ablative CO2 laser resurfacing system. The skin resurfacing surgery tool "combines the proven effectiveness of an ablative approach with the patient comfort level and convenience of a non-ablative solution," the company says.
The Pixel CO2 system and the recently approved Pixel CO2 OMNIFIT handpiece comprise the company's Pixel Perfect treatment, which promises to visually eliminate years from the face by replacing photo-damaged skin with healthy, fresh skin and stimulating new collagen growth. Pixel Perfect is touted to improve texture and tone to reduce and diminish the appearance of fine lines, wrinkles, and even acne scars. It works by creating thousands of microscopic perforations while leaving the skin intact, allowing the skin's top layer to heal rapidly and significantly improving the complexion. It claims to shorten healing time considerably (taking ablative patient downtime from 30 days to approximately three) and boasts a lower risk of complications as compared to traditional laser skin resurfacing. Any area of the skin that has surface irregularities can be treated, including the neck, chest, thighs, hands and arms.
In May 2008, the FDA approved Alma's Harmony(XL) platform for multiple aesthetic laser and light treatments, and in January 2008 the company announced a proposed IPO.
Alma Lasers Pixel CO2