
Iridex Corporation
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IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) is an FDA 510(k)-cleared medical device (K143154) manufactured by Iridex Corporation. This device is classified under the General, Plastic Surgery specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on January 1, 2015. Regulation: 8.