510(k) K223132

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) by Iridex Corporation — Product Code HQF

K223132 is an FDA 510(k) premarket notification submitted by Iridex Corporation for the device "Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)". The FDA issued a decision of Substantially Equivalent on November 9, 2022. 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.