CIRRUS™ HD-OCT Model 6000

CIRRUS™ HD-OCT Model 6000 is an FDA 510(k)-cleared medical device (K233933) manufactured by Carl Zeiss Meditec, 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 May 16, 2024. Regulation: 8.