SPECULAR MICROSCOPE CEM-530

SPECULAR MICROSCOPE CEM-530 is an FDA 510(k)-cleared medical device (K130565) manufactured by Nidek Co., Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on November 26, 2013. Regulation: 8.