Hologic Receives Expanded FDA 510(k) Clearance to Market Cynosure's SculpSure®

Hologic Receives Expanded FDA 510(k) Clearance to Market Cynosure's SculpSure® for Non-Invasive Body Contouring (Lipolysis) of Back, Inner and Outer Thighs
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SculpSure Now Cleared to Treat Five Areas of the Body

Hologic, Inc. (Nasdaq: HOLX) has announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for Cynosure's non-invasive body contouring product, SculpSure, to treat the back and inner and outer thighs. The SculpSure treatment is already FDA-cleared for treatment of the abdomen and love handles (flanks).


SculpSure is a clinically proven, non-surgical body contouring (lipolysis) treatment designed to permanently eliminate fat cells in problem areas. Developed by Cynosure, a world leader in medical aesthetics and division of Hologic, SculpSure utilizes a selective wavelength laser that precisely targets fat cells under the skin. The laser raises the temperature of body fat to disrupt and destroy these cells, which are naturally eliminated over time and do not return. Patients are able to achieve desired results – without downtime or surgery – through customized treatment plans, each lasting only 25 minutes.


"The approval of SculpSure to treat back fat and the inner and outer thighs is a direct response to the growing needs of our consumers, who are looking to achieve a slimmer appearance and enhance the body they work hard to maintain," said Michael Davin, Divisional President of Cynosure at Hologic. "Cynosure is a leader in medical aesthetics and pioneer in light-based fat reduction, and we expect the addition of three known body problem areas to SculpSure's already advanced, versatile treatment to further drive demand and pave the way for future innovations."


Source & Image Credit: Hologic

Published on : Fri, 16 Jun 2017



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Hologic,Cynosure,SculpSure® ,lipolysis,medical aesthetics, SculpSure, fat cells, Michael Davin Hologic, Inc. (Nasdaq: HOLX) has announced that the U.S. Food and Drug Administration (FDA) has granted an expanded clearance for Cynosure's non-invasive body contouring product, SculpSure, to treat the back and inner and outer thighs.

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