UltraShape Ltd., the makers of the UltraShape body contouring and fat reduction system, has announced that it has applied for a request for clearance of its Contour I system with the United States Food and Drug Administration. The company is seeking approval under the 510(k) regulation rather than as Pre-Market Approval (PMA). This means that the company may receive approval more quickly, because the submission and clearance process with the FDA will be shortened.
According to Assaf Eyal, UltraShape CEO, “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 Untied States and China, provide us with a major growth opportunity.”
The Contour I System is currently begin marketed in more than 50 countries in Europe, Asia, South America, North America, Canada and Mexico. The company has introduced several products to U.S. markets since 2005, and medical spas and cosmetic surgery centers around the world have treated over 175,000 patients.
The Contour I device works using focused ultrasound energy waves to disrupt the fat cells and assist with fat cell tissue breakdown, without affecting the surrounding structures. Contour I is a trademark of UltraShape Ltd., and has not been approved for sale in the United States.
UltraShape is a non-invasive fat reduction system that promises to deliver results in as little as two weeks after treatment. There is no bruising or swelling involved with this procedure, and no downtime. Some practitioners believe that this is the “gold standard” in fat reduction and body contouring, and can safely reduce fat deposits in both men and women.