
Clarity Medical Systems
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RETCAM PORTABLE OPHTHALMIC IMAGING SYSTEM, MODEL RCP is an FDA 510(k)-cleared medical device (K083771) manufactured by Clarity Medical Systems. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 29, 2009. Regulation: 8.