510(k) K213592

Iridex 810 Laser by Iridex Corporation — Product Code HQF

K213592 is an FDA 510(k) premarket notification submitted by Iridex Corporation for the device "Iridex 810 Laser". The FDA issued a decision of Substantially Equivalent on March 23, 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.