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I-Optics BV
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EASYSCAN MODEL 1.2 is an FDA 510(k)-cleared medical device (K111988) manufactured by I-Optics BV. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on October 27, 2011. Regulation: 8.