ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM

ANTERIOR EYE-SEGMENT ANALYSIS SYSTEM is an FDA 510(k)-cleared medical device (K991284) manufactured by Nidek, 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 August 5, 1999. Regulation: 8.