Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) is an FDA 510(k)-cleared medical device (K230228) manufactured by Iridex Corporation. This device is classified under the Ophthalmic specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on February 22, 2023. Regulation: 8.