FDA clears UltraShape Power for abdominal fat reduction
Syneron Medical announced in mid-July FDA clearance of its noninvasive UltraShape Power device for fat reduction around the abdomen.
According to press materials for the device, while ultrasound measurement reveals cryolipolysis reduces fat thickness by 22% and the 1060 nm laser by 24%, UltraShape Power reduces abdominal fat layer thickness by 32%.
The device, which uses pulsed mechanical ultrasound energy to seek and destroy fat, features the USculpt transducer, which delivers 20% more energy than its predecessor.
“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," according to Suzanne Kilmer, M.D., founding director of the Laser & Skin Surgery Center of Northern California, in a Syneron press release.
The result is a system that offers customizable treatments, according to Alix Charles, M.D., clinical trial investigator.
"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," Dr. Charles says in the release.
Full abdominal fat reduction treatment with the device can be done in close to 30 minutes, according to the release.
Beverly Hills, Calif., dermatologic surgeon Jason Emer, M.D., tells Cosmetic Surgery Times that it’s too early to tell how UltraShape Power will compare to other noninvasive fat reduction devices.
“I… feel UltraShape is great for people who are already thin, without much pinchable fat, who have small problem areas or irregularities,” Dr. Emer says. “The numbers on the study show a small percentage difference, so it will be hard to say how this will measure up in real practice. Although UltraShape has the advantage of being able to treat any size and shape of an area and is virtually painless…, it still takes a number of treatments to see the ultimate outcome, as compared to SculpSure [Cynosure] or CoolSculpting [Zeltiq], which show a large improvement in a single treatment.”
Dr. Emer says he hasn’t used the upgraded power feature yet, but is excited to try it for high-definition sculpting of the abdominal muscles.
“Ultimately, with all these treatments, you need to educate patients on long-term diet and exercise, and integrating these treatments into their daily lifestyles,” he says.
Disclosure: Dr. Emer is a consultant/luminary for Syneron-Candela and BTL Aesthetics.