Syneron Gets FDA Clearance To Market UltraShape System For Fat Cell Destruction

(RTTNews) - Syneron Medical Ltd. (ELOS) announced Monday that it has received the United States Food and Drug Administration (FDA) 510(k) clearance to market the UltraShape System for non-invasive reduction of abdominal circumference via fat cell destruction.

According to the company, the UltraShape System is the first and only non-invasive body shaping treatment that uses pulsed focused ultrasound energy that precisely targets subcutaneous fat, while keeping the surrounding tissue, vasculature, nerves and muscles intact. Unlike other body shaping technologies, UltraShape uses a pure mechanical effect to destroy fat cells without inducing thermal damage. This unique feature of the UltraShape technology results in a safe and comfortable treatment experience.

The company said it plans to limit the highly anticipated initial launch of UltraShape in the US in 2014 to a select list of key opinion leaders in aesthetic medicine. In parallel to the US effort it plans to gradually implement similar models in international markets, in which the lack of FDA clearance of the technology was a drawback to its growth. It expects to see the full impact of this effort in 2015.