injectable filler

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.

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FDA Agrees to UltraShape 510(k) Pathway – Expected to Shorten FDA Clearance Process