16.02.2005 23:38:00
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Syneron Files with FDA for 510k Clearance of the VelaSmooth System in
Business Editors/Healthcare Editors
YOKNEAM, Israel--(BUSINESS WIRE)--Feb. 16, 2005--Syneron Medical Ltd. (NASDAQ: ELOS), an innovator in the development, marketing and sales of ELOS(TM) combined-energy medical aesthetic devices, today announced that it has filed a 510(k) application with the FDA for marketing clearance of its VelaSmooth(TM) system in the U.S.
The VelaSmooth is already being sold in Europe, Canada and other countries. It was cleared in these countries for improvement in the appearance of cellulite through the Medical CE mark in Europe, and Health Canada clearance in Canada.
About Syneron
Syneron Medical Ltd. (NASDAQ: ELOS) manufactures and distributes medical aesthetic devices that are powered by the proprietary, patented ELOS(TM) 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 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 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.
--30--JO/bo*
CONTACT: Syneron Inc. Domenic Serafino, 905-886-9235 ext. 247 President doms@syneron.com or Moshe Mizrahy, +972 4 909-6200 CEO of Syneron Medical Tel. moshem@syneron-med.com
KEYWORD: ISRAEL INTERNATIONAL AFRICA/MIDDLE EAST INDUSTRY KEYWORD: MEDICAL MEDICAL DEVICES CONSUMER/HOUSEHOLD SOURCE: Syneron Medical Ltd.
Copyright Business Wire 2005
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