Syneron Medical, a leading global aesthetic device company, announced the US Food and Drug Administration (FDA) clearance of the U-Sculpt transducer for its UltraShape non-invasive fat destruction platform.
The FDA also cleared the V3.1 platform for 25% increase in Ultrasound power in the new U-sculpt transducer and the previously cleared larger VDF transducer. This 25% power enhancement is designed to increase the efficacy of treatment and improve both the user experience and patient comfort.
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% 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.
"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"