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Nidek Co., Ltd.
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NIDEK MULTICOLOR SCAN LASER PHOTOCOAGULATOR MC-500 VIXI is an FDA 510(k)-cleared medical device (K111493) manufactured by Nidek Co., Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on July 26, 2011. Regulation: 8.