Syneron Medical Ltd. reports the FDA approval of its system for cellulite:
… the US Food & Drug Administration (FDA) has granted 510(k) pre-marketing clearance to Syneron’s VelaSmooth medical device, powered by elos, for the temporary reduction in the appearance of cellulite. The VelaSmooth also received clearance for the relief of minor muscle aches, pain and spasm and the temporary improvement of local blood circulation. The clearance of the VelaSmooth offers a new non-surgical, no downtime alternative for patients wishing to treat the appearance of cellulite.
“The VelaSmooth incorporates a combination of technologies enabling deeper heating and mechanical manipulation of cellulite in a non-invasive manner,” said Dr. Tina Alster, director of the Washington Institute of Dermatologic Laser Surgery and clinical professor of dermatology at Georgetown University. “In our clinical study of 20 women of various ages and skin types with moderate thigh and buttock cellulite, significant clinical improvement was observed in skin contour irregularities, and thigh circumferences were also reduced. Patients didn’t lose weight, but they looked as if they had. Our research has shown that it is no longer necessary to endure painful and lengthy recovery times or be exposed to general anesthesia that is typical of other procedures like liposuction in order to achieve improvement of cellulite.”
In addition to the 510(k) clearance, the FDA created a new product code for the VelaSmooth, confirming its unique position in the aesthetic device market. According to Dr. Amir Waldman, head of Clinical and Regulatory Affairs for Syneron, “The FDA’s designation of a new product category specifically for the VelaSmooth reaffirms how technically innovative this device is for the treatment of cellulite.”