UltraShape said that FDA advised it to submit a request for clearance of its Contour I system under the 510(k) regulation rather than as a Pre-Market Approval (PMA) as was previously advised.
Proceeding under the 510(k) pathway is expected to simplify and shorten the submission process to the FDA for clearance to sell UltraShape’s Contour I system in the US.
Currently, the Contour I system is marketed in more than 50 countries in Europe, South America, Asia and North America, including Canada and Mexico. The Contour I system has not been approved for sale in the US.
Assaf Eyal, CEO of UltraShape, said: “Submission for FDA market clearance under the 510(k) regulation is a major milestone for UltraShape. The recent launch of our new third generation product, together with our efforts to gain regulatory approval in the US and China, provide us with a major growth opportunity.”
UltraShape develops, manufactures and markets non-invasive technologies for fat reduction and body contouring. UltraShape’s technology uses focused ultrasound that targets and selectively disrupts fat cells without affecting surrounding structures.