FDA Clears Syneron Candela's UltraShape Power for Fat Destruction

The FDA cleared Syneron Medical Ltd.'s non-invasive fat destruction device, UltraShape Power. 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  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, positioning UltraShape Power as a powerful solution for non-invasive fat reduction.

"UltraShape Power represents the latest advancement in non-thermal focused ultrasound for fat destruction. 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. The outcomes observed using UltraShape Power have been positive and our patient experience has been very satisfactory," says 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.

"The new UltraShape Power system allows for fully customizable treatments that meet the unique needs of each patient," says Alix Charles, MD, FAAD, clinical trial investigator, from Dupage Medical Group, Hinsdale, IL. "The clinical studies show a pain score of less than one out of a ten point scale, and my patients have experienced similar comfort levels."

"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. We believe that this new generation of UltraShape will have a significant impact on our ability to continue building our global leadership position in the fast growing, non-invasive fat destruction market," says Amit Meridor, CEO of Syneron Candela.

Discussing the third quarter 2016 market launch of the UltraShape Power in the United States, Jeff Nardoci, President, North American Body Group says, "We look forward to launching our new UltraShape Power campaign following the ramp up of our installations. Initial testing outcomes indicate that the campaign resonates well with consumers and carries through with our professional audience as well. The UltraShape Power's increased energy provides greater efficacy and high comfort, while the device's advanced treatment modes allow us to treat a full abdomen in close to 30 minutes.  WiFi connectivity allows for remote diagnostics and scheduling support. We believe the combination of these features provides the professional market with a very strong value proposition in the arena of non-invasive fat destruction," he concludes.