510(k) K230228

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) by Iridex Corporation — Product Code HQF

K230228 is an FDA 510(k) premarket notification submitted by Iridex Corporation for the device "Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)". The FDA issued a decision of Substantially Equivalent on February 23, 2023. The device falls under product code HQF (Laser, Ophthalmic), a Class II device regulated under 21 CFR 886.4390. Iridex Corporation has at least 8 other 510(k) clearances on record.