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July 7, 2015

FDA clears Cynosure to market SculpSure for non-invasive lipolysis of the abdomen

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Cynosure to market SculpSure for non-invasive lipolysis of the abdomen.

The US Food and Drug Administration (FDA) has granted 510(k) clearance to Cynosure to market SculpSure for non-invasive lipolysis of the abdomen.

Using patented technology, SculpSure is designed to reduce fat non-invasively by disrupting subcutaneous fat cells.

The versatile, hands-free, clinically proven and safe treatment device features a flexible applicator system to treat multiple anatomical areas of the body.

"SculpSure is the world’s first hyperthermic laser treatment for the non-invasive reduction of fat from the abdomen."

In addition, the device uses a 1,060nm laser, and can treat an anatomical area in approximately 25 minutes, offering desired results to patients without downtime or surgery.

Bass Plastic Surgery plastic surgeon Dr Lawrence Bass said: "SculpSure is the world’s first hyperthermic laser treatment for the non-invasive reduction of fat from the abdomen.

"Subjects in our study saw a statistically significant reduction in adipose layer thickness, with more than 90% reporting they were satisfied with the treatment."

Cynosure CEO Michael Davin said: "The abdomen and flanks are two areas of the body that are often difficult to target with diet and exercise alone, so the fact that SculpSure can now effectively treat both of these regions is great news for consumers.

"It’s also a significant achievement for our company, demonstrating the initial breadth of our non-invasive fat reduction platform.

"We believe that SculpSure’s versatility and fast treatment time are key competitive advantages that will drive demand for the technology among aesthetic practitioners and their patients."

In May, SculpSure was cleared by the FDA for non-invasive lipolysis of the flanks. The company plans to launch the device in the US in the second half of this year.

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