PASCAL STREAMLINE 577 (WITH ACCESSORIES)

PASCAL STREAMLINE 577 (WITH ACCESSORIES) is an FDA 510(k)-cleared medical device (K111108) 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 August 10, 2011. Regulation: 8.