
Optos Plc.
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OPTOS OCT/SLO MICROPERIMETER is an FDA 510(k)-cleared medical device (K121043) manufactured by Optos Plc.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 21, 2013. Regulation: 8.