PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER

PASCAL SYNTHESIS (532NM/577NM) OPTHALMIC LASER is an FDA 510(k)-cleared medical device (K123542) 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 14, 2013. Regulation: 8.