
Topcon Medical Laser Systems, Inc. (Tmls)
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PASCAL Synthesis Twinstar Ophthalmic Scanning Laser System is an FDA 510(k)-cleared medical device (K170409) manufactured by Topcon Medical Laser Systems, Inc. (Tmls). 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 September 11, 2017. Regulation: 8.