The body contouring laser treatment SculpSure (Cynosure Inc) has received 510(k) clearance from the US Food and Drug Administration (FDA) to treat the submental area (double chin), marking the product’s sixth cleared body treatment area, parent company Hologic Inc has announced.
SculpSure is already cleared for the reduction of fat in the abdomen, flanks, back, and inner and outer thighs.
Lawrence Bass, MD, a New York City–based board certified plastic surgeon, was a principal investigator in the SculpSure clinical trials. “Most patients in the 57-person clinical trial received two brief treatments 6 weeks apart. The short treatment time, 100% satisfaction rate, and dramatic contour reductions typically seen in the study patients give SculpSure the edge as the treatment of choice for the submental area,” Dr Bass said in a news release.
SculpSure is a fully customizable body contouring treatment that helps patients achieve a natural-looking, slimmer appearance, the company notes. The laser raises the temperature of body fat to precisely disrupt and destroy fat cells under the skin, which are then naturally and permanently eliminated over time. Each laser treatment takes about 25 minutes and requires no surgery or downtime.
The treatment was proven effective on patients with a body mass index (BMI) up to 43, while competitor products in the noninvasive arena are FDA-cleared only to treat patients with a BMI up to 30, noted Kevin Thornal, divisional president of Cynosure at Hologic, in the release.
More information on SculpSure is available on the manufacturer website.
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