COHERENT FUNDUSL RETINAL CAMERA

COHERENT FUNDUSL RETINAL CAMERA is an FDA 510(k)-cleared medical device (K822908) manufactured by Coherent Medical Division. 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 4, 1983. Regulation: 8.