Home » Syneron to File 510(k) for Marketing Clearance of VelaSmooth
Syneron to File 510(k) for Marketing Clearance of VelaSmooth
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.
MENAFN
KEYWORDS FDAnews Device Daily Bulletin
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