07.07.15
Westford, Mass.-based Cynosure Inc., which makes laser- and light-based aesthetic treatments, has received 510(k) clearance from the U.S. Food and Drug Administration (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 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. Cynosure claims that Sculpsure, which uses a 1060 nm laser, can treat an anatomical area in approximately 25 minutes. The goal is for patients to be able to achieve desired results without downtime or surgery. The expected U.S. launch date is 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 Lawrence S. Bass, M.D., 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 percent reporting they were satisfied with the treatment.”
“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,” said Cynosure CEO Michael Davin. “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.”
Sculpsure is 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. Cynosure claims that Sculpsure, which uses a 1060 nm laser, can treat an anatomical area in approximately 25 minutes. The goal is for patients to be able to achieve desired results without downtime or surgery. The expected U.S. launch date is 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 Lawrence S. Bass, M.D., 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 percent reporting they were satisfied with the treatment.”
“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,” said Cynosure CEO Michael Davin. “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.”