FDA Agrees to UltraShape 510(k) Pathway – Expected to Shorten FDA Clearance Process
UltraShape Ltd. announced today that the US Food and Drug Administration advised the company that it may 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 the Company’s Contour I system in the United States.
UltraShape CEO, Assaf Eyal, said “The United States is the largest and most important market in the world, and represents a huge opportunity for our products. 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 United States and China, provide us with a major growth opportunity.”
Currently, the Contour I system is marketed in more than 50 countries in Europe, South America, Asia and North America, including Canada and Mexico. Since introduction of the company’s products in 2005, more than 175,000 patient treatments have been performed worldwide.
About UltraShape
UltraShape redefines aesthetic medicine by developing, manufacturing and marketing innovative non-invasive technologies for fat reduction and body contouring. The company provides clinically proven safe and effective solutions that enhance the lives of patients. UltraShape’s proprietary technology uses focused ultrasound that targets and selectively disrupts fat cells without affecting surrounding structures. Founded in 2000, UltraShape has sold Contour I devices worldwide, demonstrating safety and efficacy of its novel technology.
The Contour I system has not been approved for sale in the United States.
Contour I is a trademark and UltraShape(R) is a registered trademark of UltraShape Ltd.
UltraShape Ltd. is a unit of UltraShape Medical Ltd. (Tel Aviv: ULSP)
