Cynosure's SculpSure Receives Expanded FDA Clearance for Lipolysis of the Abdomen

Cynosure, Inc. has received 510(k) clearance from the FDA to market SculpSure™ for non-invasive lipolysis of the abdomen. In May, the FDA cleared SculpSure for non-invasive lipolysis of the flanks.

SculpSure is a safe, clinically proven treatment designed to reduce fat non-invasively by disrupting subcutaneous fat cells. The hands-free device features a flexible applicator system to treat multiple anatomical areas of the body. SculpSure, which uses a 1060nm laser, can treat an anatomical area in approximately 25 minutes. Patients are able to achieve desired results without downtime or surgery. The technology is expected to be launched in the US in the second half of 2015.

"SculpSure is the world's first hyperthermic laser treatment for the non-invasive reduction of fat from the abdomen," said plastic surgeon Dr. Lawrence S. Bass, MD, of Bass Plastic Surgery PLLC, who participated in the clinical evaluation of SculpSure. "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."