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Opto Global, Inc.
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OPTO GLOBAL DIGITAL FUNDUS CAMERA SYSTEM MODEL ADS 1.5 is an FDA 510(k)-cleared medical device (K053044) manufactured by Opto Global, 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 January 23, 2006. Regulation: 8.