RESCAN 700, CALLISTO EYE

RESCAN 700, CALLISTO EYE is an FDA 510(k)-cleared medical device (K141844) manufactured by Carl Zeiss Meditec, AG. 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 17, 2014. Regulation: 8.