PLEX Elite 9000 SS-OCT

PLEX Elite 9000 SS-OCT is an FDA 510(k)-cleared medical device (K161194) 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 October 25, 2016. Regulation: 8.