Compelo Medical Devices is using cookies

We use them to give you the best experience. If you continue using our website, we'll assume that you are happy to receive all cookies on this website.

ContinueLearn More

UltraShape To Submit Contour I System For FDA Clearance Under 510(k) Regulation

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.