The U.S. Food and Drug Administration (FDA) has given clearance of Syneron Candela’s non-invasive fat destruction device, UltraShape PowerT. The FDA clearance is for non-invasive reduction of abdominal circumference via fat cell destruction.
UltraShape Power uses focused, pulsed mechanical ultrasound energy to target and destroy fat, offering measurable fat reduction to the abdominal area. UltraShape Power’s advanced USculpt transducer delivers 20 percent more energy than its predecessor. A recent clinical study with UltraShape Power’s USculpt transducer documents a 32 percent reduction in subcutaneous fat thickness.
“The device’s unique deployment of higher acoustic energy via its new transducer allows for the precise targeting of small and large pockets of fat with minimal increase in tissue temperature, resulting in a comfortable treatment experience,” said Suzanne Kilmer, MD, FAAD, Founding Director of the Laser & Skin Surgery Center of Northern California.
UltraShape Power’s ultrasound energy is applied to the skin in a proprietary pulse structure to ensure effective fat destruction with no damage to surrounding tissue including blood vessels, nerves and muscles, resulting in a safe and comfortable treatment experience.
UltraShape Power’s lighter transducer for high maneuverability enables the customized treatment of large and small fat pockets. The device also incorporates a sophisticated treatment and patient management software package combined with flexible communication options.
“We are pleased to announce that we have received FDA clearance for UltraShape Power in the US. UltraShape Power’s strong market acceptance since its launch in the second quarter 2016 outside of the U.S. has been driven by its powerful non-invasive fat reduction capability, patient comfort and an emphasis on ease of use,” said Syneron Candela CEO Amit Meridor.
