VelaSmooth™ Therapy – FDA Gives Approval for Cellulite Treatment
Austin, TX – June 16, 2005 – Syneron Medical Ltd. announced earlier this week the US Food & Drug Administration (FDA) 510(k) pre-marketing clearance of the VelaSmooth™ medical device for the temporary reduction in the appearance of cellulite. VelaSmooth™ offers a non-surgical, no downtime alternative for patients wishing to treat the appearance of cellulite.
The innovative VelaSmooth™ treatment combines radiofrequency waves, a laser, and a mechanical massage to break up the fat and mobilize the water from tissues to safely and effectively re-contour the skin’s surface, specifically where problem areas of cellulite occur. In addition to the 510(k) clearance, the FDA created a new product category for VelaSmooth™. According to Dr. Amir Waldman, head of Clinical and Regulatory Affairs for Syneron, this designation of a new product category “reaffirms how technically innovative this device is for the treatment of cellulite.”
Dr. Gregory Nikolaidis, founder of Westlake Dermatology & Cosmetic Surgery, was one of the first physicians in the United States offering VelaSmooth™ treatments to patients. Since November, approximately 500 treatments have been performed at the practice. Dr. Nikolaidis often combines VelaSmooth™ treatments with mesotherapy for even more dramatic results.
Dr. Nikolaidis’ experience and expertise is sought by laser companies like Syneron, and he is currently featured on the Syneron website (www.syneron.com).