
O.P.T. USA, Inc.
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OPT80 THE TRANSPORTABLE (OPT80) is an FDA 510(k)-cleared medical device (K972810) manufactured by O.P.T. USA, Inc.. This device is classified under the General, Plastic Surgery specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on August 25, 1997. Regulation: 8.