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Dermatology

U.S. FDA gives OK to marketing clearance application for cellulite device

Published in Medical Letter on the CDC and FDA, March 6th, 2005

Syneron Medical Ltd. (ELOS) and its North American subsidiary Syneron Inc., which develops markets and sells ELOS combined-energy medical aesthetic devices, has received permission to file for market clearance for the VelaSmooth system.

Clearance was granted in a recent meeting between senior company officials and representatives of the U.S. Food & Drug Administration (FDA) at which the FDA representatives stated it appears reasonable for Syneron to submit a 510(k) pre-market notification to the FDA for marketing clearance of its VelaSmooth system in the U.S.

The VelaSmooth is sold in Europe and Canada and in other countries around the world. It was...

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