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Medical Devices / Submissions and Approvals

Syneron Candela Receives FDA Clearance Of Profound SubQ

Nov. 9, 2016
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Syneron Candela has received FDA 510(k) clearance for Profound when using the SubQ hand-piece and cartridge to improve the appearance of cellulite.

According to the clinical study of Profound, it showed improvement of cellulite severity in 94 percent 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.

Syneron Candela plans to release the product in 2017. — Cynthia Jessup

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