FDA approves the UltraShape System for Lipoplasty - Syneron Medical

Syneron Medical has received FDA 510(k) clearance to market the UltraShape System (pulsed focused ultrasound) for Lipoplasty, or non-invasive reduction of abdominal circumference via fat cell destruction. The UltraShape System 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.

Approval is based on a randomized, controlled clinical study of UltraShape which was performed at three clinical sites in the US and one site outside of the US. Patients demonstrated an average reduction of 2.5 cm in the treatment phase and 0.5 cm reduction in the control phase. The results demonstrated progressive improvement over time in circumference reduction, beginning after the first treatment session with UltraShape. The treatment was administered without the need for anesthetic and was well tolerated by patients. No serious adverse events were reported.