Cynosure Receives FDA 510(k) Clearance For SculpSure - Quick Facts

(RTTNews) - Cynosure, Inc. (CYNO) announced that it has received 510(k) clearance from the U.S. Food and Drug Administration or FDA to market SculpSure, the world's first hyperthermic laser treatment for non-invasive lipolysis of the flanks.

Cynosure said it plans to introduce SculpSure through its U.S. direct sales force late in the second half of 2015.

Utilizing patented technology, SculpSure is a clinically proven and safe treatment designed to reduce fat non-invasively by disrupting subcutaneous fat cells, the company stated.

The versatile, hands-free device features a flexible applicator system to treat multiple anatomical areas of the body. SculpSure, which uses a 1060 nm laser, can treat an anatomical area in approximately 25 minutes. Patients are able to achieve desired results without downtime or surgery.