
Topcon Medical Laser Systems, Inc.
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PASCAL STREAMLINE PHOTOCOAGULATOR is an FDA 510(k)-cleared medical device (K092621) manufactured by Topcon Medical Laser Systems, Inc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 24, 2009. Regulation: 8.