FDA Clears Syneron Candela's Profound SubQ to Improve Cellulite


Syneron Candela  received FDA 510(k) clearance for Profound when using the SubQ handpiece and cartridge to improve the appearance of cellulite in patients with Fitzpatrick skin types I-III, as supported by long term data (6 months).

A recent multi-center clinical study of Profound showed improvement of cellulite severity (in dimples and/undulation irregularities) in 94 percet of treated thighs assessed at a three month follow up by blinded review. Sustained improvement was observed at six month follow up in 93 percent of the treated thighs. When considering improvement in each cellulite feature separately, 86 percent of the treated thighs (of the 80 thighs with dimples at baseline) showed improvement in dimples, and 76 percent of the thighs (all thighs had undulation at baseline) showed improvement in undulation irregularities. Per subject results were similar, where 88 percent of the treated subjects showed improvement in the appearance of cellulite in both thighs in dimples and/or undulation at 3 months follow up, and 86 percent of the treated subjects showed improvement at 6 months follow up. 

"There has been an increased demand for treatments that can impact the appearance of cellulite over the past few years as it's a driver of insecurities in both men and women," said Macrene Alexiades, MD, PhD, Associate Clinical Professor, Yale University School of Medicine, and Director & President of Dermatology & Laser Surgery Center of New York. "Profound is an optimal treatment for patients with cellulite who are apprehensive about invasive procedures, as well as for those who are looking to improve the appearance of areas impacted by cellulite in a single treatment. Some subjects showed improvement starting at one month after treatment."

FDA clearance for Profound to improve the appearance of cellulite using the SubQ cartridge and handpiece is based on positive data from utilizing the device in an institutional review board (IRB) reviewed multi-center study. The study measured success by analyzing the dimples and/or undulation irregularities in the thighs of 50 women with Fitzpatrick skin types I-III. Syneron Candela plans to release the product in 2017.

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