CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ

CLINICAL SPECULAR MICROSCOPE, MODEL HAI CL-1000XYZ is an FDA 510(k)-cleared medical device (K994340) manufactured by Hai Laboratories, 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 September 19, 2000. Regulation: 8.