Syneron Medical has received the US Food and Drug Administration (FDA) 510(k) clearance to market the UltraShape system, designed for non-invasive reduction of abdominal circumference via fat cell destruction.
It is claimed to be the only system to use pulsed focused ultrasound energy to precisely target subcutaneous fat, while keeping the surrounding tissue, vasculature, nerves and muscles intact.
The non-invasive body shaping technology uses a pure mechanical effect to destroy fat cells without inducing thermal damage. This unique feature of the UltraShape technology results in a safe and comfortable treatment experience.
Syneron CEO Amit Meridor said the company plans to limit the highly anticipated initial launch of UltraShape in the US in 2014 to a select list of key opinion leaders in aesthetic medicine.
"In parallel to the US effort we plan to gradually implement similar models in international markets, in which the lack of FDA clearance of the technology was a drawback to its growth. We expect to see the full impact of this effort in 2015," Meridor added.
In the randomized, controlled clinical study of UltraShape which was performed at three clinical sites in the US and one site outside of the US, a total of 150 subjects were treated and followed for up to four months. In this multi-site study, patients demonstrated an average reduction of 2.5 cm in the treatment phase and 0.5 cm reduction in the control phase.
The UltraShape system received CE mark in 2005 and is marketed in European countries, Canada, and Asia Pacific countries.
The device has been used in over 220,000 procedures worldwide, with a positive safety and effectiveness profile.