
Trimedyne, Inc.
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OPTILASE MODEL 1000 ND:YAG LASER ADD'L INDICATION is an FDA 510(k)-cleared medical device (K902263) manufactured by Trimedyne, Inc.. This device is classified under the Hematology specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on July 22, 1990. Regulation: 8.