CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR

CRYSTAL FOCUS EMERALD-CW LASER PHOTOCOAGULATOR is an FDA 510(k)-cleared medical device (K904366) manufactured by Douglas James Donaldson Compliance Services. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 18, 1990. Regulation: 8.