Syneron Candela Expands Capabilities of UltraShape Platform, Receives FDA Clearance for the New U-Sculpt Transducer and Enhanced Ultrasound Power

November 17, 2014

The FDA cleared Syneron Medical Ltd.'s U-Sculpt transducer for the UltraShape non-invasive fat destruction platform. The FDA also cleared the V3.1 platform for a 25 percent increase in Ultrasound power in the new U-sculpt transducer and the previously cleared larger VDF transducer. This 25 percent power enhancement is designed to increase the efficacy of treatment and improve both the user experience and patient comfort, according to the company.

The UltraShape System is a non-invasive body shaping treatment that uses pulsed focused ultrasound energy to precisely target 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.

With this new clearance, the UltraShape system is now available with two transducers, the currently cleared VDF transducer as well as the new U-Sculpt transducer. The new U-Sculpt transducer is smaller and 50 percent lighter than the existing full-size VDF transducer, it is ergonomically designed to treat any shape and size of fat pockets and is easily interchangeable with the full-size VDF transducer during treatment sessions. With the new FDA clearance the VDF transducer can be operated in two energy density levels and utilizes four available treatment modes.

"As a long time and satisfied UltraShape user, I find the new U-Sculpt transducer a great enhancement to our treatments," commented Christopher Inglefield BSc, FRCS, a Plastic Surgeon in London UK. "The U-Sculpt transducer gives me the flexibility to fully customize the treatment of small pockets of fat in any areas.  In my practice, 98% of patients reported satisfaction with the UltraShape procedure confirming that it is meeting patient expectations and the high demand for comfortable, safe and effective non-invasive fat reduction treatments."

"UltraShape is already showing remarkable success in the US since we initiated its controlled launch several months ago," stated Amit Meridor, CEO of Syneron Candela, "We are confident that the FDA clearance of U-Sculpt and enhanced power of both transducers provide additional significant features to the UltraShape platform and will further enhance the business opportunity of our UltraShape doctor partners" 

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