Cynosure’s SculpSure noninvasive body contouring laser system (now owned by Hologic) has received U.S. Food and Drug Administration (FDA) 510(k) clearance for the treatment of submental fat. The device was previously cleared to treat the abdomen, flanks, back and inner and outer thighs.
The 1060nm laser-based SculpSure raises the temperature of body fat to precisely disrupt and destroy fat cells under the skin. The new clearance was based on a clinical trial involving 57 subjects. Each received two treatments spaced six week apart. “We are encouraged that our chin treatment was proven effective on patients with a body mass index (BMI) up to 43,” said Kevin Thornal, divisional president of Cynosure at Hologic. “We are excited to provide our customers with a competitive advantage that can further widen their patient communities.”