
Eleme Medical, Inc.
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SMOOTHSHAPES SYSTEM, 11318-120V, 11319-230V is an FDA 510(k)-cleared medical device (K100230) manufactured by Eleme Medical, Inc.. 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 1, 2010. Regulation: 8.