FDAnews
www.fdanews.com/articles/68180-syneron-to-file-510-k-for-marketing-clearance-of-velasmooth

Syneron to File 510(k) for Marketing Clearance of VelaSmooth

January 31, 2005

Syneron Medical and its North American subsidiary Syneron, an innovator in the development, marketing and sales of ELOS combined-energy medical aesthetic devices, have announced that in a recent meeting between senior company officials and representatives of the FDA, the FDA representatives stated it appears reasonable for Syneron to submit a 510(k) premarket notification to the FDA for marketing clearance of its VelaSmooth system in the U.S.
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