
Syneron Medical, Ltd.
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CONTOUR I V3.1 SYSTEM is an FDA 510(k)-cleared medical device (K133238) manufactured by Syneron Medical, Ltd.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on April 9, 2014. Regulation: 8.