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Topcon Medical Systems, Inc.
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3D OCT-1000 MARK II OPTICAL COHERENCE TOMOGRAPHY SYSTEM is an FDA 510(k)-cleared medical device (K083316) manufactured by Topcon Medical Systems, 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 March 12, 2009. Regulation: 8.