PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar

PSLT with PASCAL Synthesis, PSLT with PASCAL Synthesis TwinStar is an FDA 510(k)-cleared medical device (K180402) 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 May 24, 2018. Regulation: 8.