
Topcon Medical Laser Systems, Inc.
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PASCAL PHOTOCOAGULATOR, PRODUCT-PASCAL-01 is an FDA 510(k)-cleared medical device (K043486) manufactured by Topcon Medical Laser Systems, 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 March 2, 2005. Regulation: 8.