FDA Requests Additional Information on VelaSmooth 510K Submission.YOKNEAM, Israel -- Syneron Medical Ltd. (Nasdaq:ELOS), an innovator in the development, marketing and sales of ELOS(TM) combined-energy medical aesthetic devices, today announced that the U.S. Food and 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 requested additional technical information on its 510(k) Premarket Notification application for the VelaSmooth(TM) system. Head of Clinical and Regulatory Affairs Regulatory Affairs (RA), also called Government Affairs, is a profession within regulated industries, such as pharmaceuticals, medical devices, energy, and banking. Regulatory Affairs professionals usually have responsibility for the following general areas: prep. 1. As stated or indicated by; on the authority of: according to historians. 2. In keeping with: according to instructions. 3. standard 510(k) procedure." About Syneron 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 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. . 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 North American named after North America. North American blastomycosis see North American blastomycosis. North American cattle tick see boophilusannulatus. Headquarters in Canada, European Headquarters in Germany, and Asia-Pacific Headquarters in Hong Kong Hong Kong (hŏng kŏng), Mandarin Xianggang, special administrative region of China, formerly a British crown colony (2005 est. pop. 6,899,000), land area 422 sq mi (1,092 sq km), adjacent to Guangdong prov. , which provide sales, service and support. Additional information can be found at www.syneron.com. For more information, please contact Moshe Mizrahy, CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. of Syneron Medical Ltd., at +972 4 909-6349, email: moshem@syneron.com, Dr. Amir Waldman, VP Clinical and Regulatory Affairs at +972 4 909-6352, email: amirw@syneron.com Syneron Medical Ltd. Soltam Technology Park P.O.B. 550 Yokneam Illit, 20692 Israel Tel: +972 4 909-6200 Fax: +972 4 909-6202 info@syneron-med.com Syneron, the Syneron logo, ELOS, Comet, and VelaSmooth 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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