
Trimedyne, Inc.
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RIGHT ANGLE LASER FIBERS;OPTILASE ND:YAG LASER;OPTILASE PL100 ND LASER SYSTEMS is an FDA 510(k)-cleared medical device (K970422) manufactured by Trimedyne, 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 20, 1997. Regulation: 8.