FDA Requests Resubmission of Syneron Medical's VelaSmooth Device under PMA Guidelines.YOKNEAM, Israel & TORONTO -- Syneron Medical Ltd. (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : ELOS), and its North American North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. subsidiary Syneron Inc., today announced that the U.S. Food & Drug Administration (FDA FDA abbr. Food and Drug Administration FDA, n.pr See Food and Drug Administration. FDA, n.pr the abbreviation for the Food and Drug Administration. ) has notified the company that it will not be able to market the VelaSmooth(TM) system in the U.S. with a 510K pre-market notification and asked the company to resubmit Verb 1. resubmit - submit (information) again to a program or automatic system feed back return, render - give back; "render money" the device with a PMA PMA (papillary-marginal-attached), n a system of epidemiologic scoring of periodontal disease devised by Schour and Massler in which the symbols denote the areas involved in gingival inflammation. PMA Progressive muscular atrophy application. The VelaSmooth, which was cleared for non-invasive treatment of cellulite cel·lu·lite n. A fatty deposit causing a dimpled or uneven appearance, as around the thighs. Cellulite Cellulite is dimply skin caused by uneven fat deposits beneath the surface. in Europe under the Medical CE mark and in Canada under Health Canada Health Canada (French: Santé Canada) is the department of the government of Canada with responsibility for national public health. Health Canada's goal is to improve Canadian life by improving Canadian longevity, lifestyle and use of public healthcare. clearance, is sold outside of the U.S. on the basis of these clinical clearances. Syneron intends to submit to the FDA a request for an IDE for the VelaSmooth in order to enable its clearance by the FDA via the alternative PMA route. "We will be working expeditiously ex·pe·di·tious adj. Acting or done with speed and efficiency. See Synonyms at fast1. ex , thoroughly and cooperatively to provide the FDA all of the information they require. The delay in the clearance of VelaSmooth is disappointing but we believe that it demonstrates the unique clinical potential of the device and will enhance its competitive advantage in the body shaping market place," commented Dr. Amir Waldman, Vice President, Clinical and Regulatory Affairs, Syneron Medical Ltd. About Syneron Medical Ltd. Syneron Medical Ltd. (NASDAQ: ELOS) manufactures and distributes medical aesthetic devices that are powered by the proprietary, patented ELOS combined-energy technology of Bi-Polar Radio Frequency and Light. The Company's innovative ELOS technology provides the foundation for highly effective, safe and cost-effective systems that enable physicians to provide advanced solutions for a broad range of medical-aesthetic applications, including hair removal, wrinkle reduction, rejuvenating the skin's appearance through the treatment of superficial benign vascular and pigmented lesions, and the treatment of acne, leg veins and cellulite. Founded in 2000, the corporate, R&D, and manufacturing headquarters for Syneron Medical Ltd. is located in Israel. Syneron has offices and distributors throughout the world, including North American Headquarters in Canada, European Headquarters in Germany, and Asia-Pacific Headquarters in Hong Kong, which provide sales, service and support. Additional information can be found at www.syneron.com. Syneron, the Syneron logo, VelaSmooth, the VelaSmooth logo, and ELOS are trademarks of Syneron Medical Ltd. and may be registered in certain jurisdictions. ELOS (Electro-Optical Synergy) is a proprietary technology of Syneron Medical. All other names are the property of their respective owners. |
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