Cynosure's SculpSure® is now cleared for submental fat reduction.
The U.S. Food and Drug Administration (FDA) granted an expanded FDA 510(k) clearance for this area, Hologic, Inc. reports.
This is the device's sixth cleared body treatment area. SculpSure® is also cleared to treat the abdomen, love handles, back, and inner and outer thighs.
Most patients in the 57-person clinical trial received two brief treatments six 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,” says Lawrence Bass, MD, New York City plastic surgeon and a principal investigator in the SculpSure clinical trials, in a news release.
"We are encouraged that our chin treatment was proven effective on patients with a body mass index (BMI) up to 43, while our competition in the non-invasive arena is only FDA-cleared to treat patients with a BMI up to 30," says Kevin Thornal, Divisional President of Cynosure at Hologic, in a news release. "We are excited to provide our customers with a competitive advantage that can further widen their patient communities."