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Iridex Corp
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IRIS MEDICAL IQ 810 PHOTOCOAGULATOR is an FDA 510(k)-cleared medical device (K040209) manufactured by Iridex Corp. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on September 19, 2004. Regulation: 8.