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Nidek Co., Ltd.
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OPD-SCAN, MODELS ARK-10000 AND ARK-9000 is an FDA 510(k)-cleared medical device (K003299) manufactured by Nidek Co., Ltd.. This device is classified under the Ophthalmic specialty. FDA Device Class I (General Controls) — lowest risk category. FDA clearance granted on March 8, 2001. Regulation: 8.