Syneron Receives FDA Clearance to Market the Ultrashape System for Fat Cell Destruction


Syneron Medical Ltd. received FDA 510(k) clearance to market the UltraShape System for 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. UltraShape uses a pure mechanical effect to destroy fat cells without inducing thermal damage. According to the company, this unique feature of the UltraShape technology results in a safe and comfortable treatment experience.

“The UltraShape technology is one of the two pillars of our body shaping strategy,” stated Shimon Eckhouse, PhD, active chairman of the board of directors of Syneron. “Our significant investment in the development of non-invasive body shaping products puts us in a unique position to lead the market with UltraShape mechanical fat destruction technology, and with our unique VelaShape III elōs based thermal technology. With these two FDA cleared technologies we have a wide range of body shaping indications including circumferential reduction in various body areas and reduction in cellulite appearance. These two complementary technologies will be key factors for serving our global customer base in the fast growing body shaping market.”  Dr. Eckhouse concluded: “our investment in the UltraShape technology of over two years resulted in a clear demonstration of the unique clinical value of this technology for safe and comfortable non-invasive fat destruction.”

"UltraShape is a nonsurgical device that precisely delivers focused ultrasound energy strong enough to destroy fat cells while leaving neighboring tissue unharmed. The benefit of UltraShape is that each treatment can be customized to the individual patient, UltraShape uses non thermal ultrasound providing efficacy and the non-heat dependent energy is tolerated well by the patients" said Jeffrey M Kenkel, MD, FACS, Professor and Vice Chairman of the Department of Plastic Surgery at the University of Texas Southwestern Medical Center at Dallas, one of the primary investigators in the multi-center IDE study.

In the randomized, controlled clinical study of UltraShape which was performed at three clinical sites in the US and one site outside of the US, a total of 150 subjects were treated and followed for up to four months. In this multi-site study, patients demonstrated an average reduction of 2.5cm in the treatment phase and 0.5cm reduction in the control phase.

"We observed clinically significant circumference reduction of truncal fat. 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," stated William Coleman MD, Clinical Professor of Dermatology, Adjunct Professor of Surgery (Plastic Surgery), Tulane University Health Sciences Center and a principal investigator in the study. "In our practice, patients were very satisfied with the results of the UltraShape treatment."

The UltraShape System received CE mark in 2005 and is marketed in European countries, Canada, and Asia Pacific countries. The device has been used in over 220,000 procedures worldwide, with a positive safety and effectiveness profile. Syneron acquired UltraShape in March 2012. Since the acquisition, Syneron's main focus has been to gain FDA regulatory clearance for the system in the United States, which opens a significant market opportunity for the product and provide

Facebook Comments


We’re glad to see you’re enjoying PracticalDermatology…
but how about a more personalized experience?

Register for free