FDA Agrees to UltraShape 510(k) Pathway
- Expected to Shorten FDA Clearance Process
UltraShape Ltd. announced today that the US Food and Drug Administrationadvised the company that it may submit a request for clearance of its ContourI 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 shortenthe submission process to the FDA for clearance to sell the Company's ContourI system in the United States.
UltraShape CEO, Assaf Eyal, said "The United States is the largest andmost important market in the world, and represents a huge opportunity for ourproducts. Submission for FDA market clearance under the 510(k) regulation isa major milestone for UltraShape. The recent launch of our new thirdgeneration product, together with our efforts to gain regulatory approval inthe United States and China, provide us with a major growth opportunity."
Currently, the Contour I system is marketed in more than 50 countries inEurope, South America, Asia and North America, including Canada and Mexico.Since introduction of the company's products in 2005, more than 175,000patient treatments have been performed worldwide.
UltraShape redefines aesthetic medicine by developing, manufacturing andmarketing innovative non-invasive technologies for fat reduction and bodycontouring. The company provides clinically proven safe and effectivesolutions that enhance the lives of patients. UltraShape's proprietarytechnology uses focused ultrasound that targets and selectively disrupts fatcells without affecting surrounding structures. Founded in 2000, UltraShapehas sold Contour I devices worldwide, demonstrating safety and efficacy ofits 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 ofUltraShape Ltd.
UltraShape Ltd. is a unit of UltraShape Medical Ltd. (Tel Aviv: ULSP)
Forward-Looking Statements This press release contains forward-lookingstatements which involve risks and uncertainties which may cause the actualresults and performance of the Company to be materially different from whatmay be expressed or implied by such forward-looking statements. You arecautioned not to place undue reliance on these forward-looking statements,which speak only as of the date of this press release. The Company undertakesno obligation to release publicly any revisions to any forward-lookingstatements or to report future events except as required by law.Contact: Inbar Elfasy-Poran UltraShape Ltd. +972-4-909 4045 firstname.lastname@example.org http://www.ultrashape.com
SOURCE UltraShape Ltd
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