Syneron Medical Ltd. (NASDAQ: ELOS) has announced that it has received the United States Food and Drug Administration (FDA) 510(k) clearance to market the UltraShape™ System for non-invasive reduction of abdominal circumference via fat cell destruction.
The UltraShape System uses pulsed focused ultrasound energy to precisely target subcutaneous fat, while keeping the surrounding tissue, vasculature, nerves and muscles intact.
‘The UltraShape technology is one of the two pillars of our body shaping strategy,’ said Shimon Eckhouse, PhD, chairman of the board of directors of Syneron. ‘Our significant investment in the development of non-invasive body shaping products puts us in a unique position to lead the market with UltraShape mechanical fat destruction technology, and with our unique VelaShape III elōs based thermal technology. With these two FDA cleared technologies we have a wide range of body shaping indications including circumferential reduction in various body areas and reduction in cellulite appearance. These two complementary technologies will be key factors for serving our global customer base in the fast growing body shaping market.’
Dr Eckhouse concluded: ‘Our investment in the UltraShape technology of over 2 years resulted in a clear demonstration of the unique clinical value of this technology for safe and comfortable non-invasive fat destruction.’
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.
Syneron acquired UltraShape in March 2012. Since the acquisition, Syneron’s main focus has been to gain FDA regulatory clearance for the system in the US, which opens a significant market opportunity for the product and provides important validation for potential customers around the world.