MODEL 150K LASER COAGULATOR

MODEL 150K LASER COAGULATOR is an FDA 510(k)-cleared medical device (K832089) manufactured by Lasertek OY. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 1984. Regulation: 8.