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Iridex Corp
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IRIS MEDICAL OCULIGHT GL/GLX LASER SYSTEMS is an FDA 510(k)-cleared medical device (K031665) 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 August 26, 2003. Regulation: 8.