Iridex Corporation - FDA 510(k) Cleared Devices
Recent clearances: Iridex 532 Laser, Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models), Iridex 810 Laser
9
Total
9
Cleared
0
Denied
FDA 510(k) Regulatory Record - Iridex Corporation Ophthalmic ✕
5 devices
Cleared
Feb 23, 2023
Iridex 532 Laser
Ophthalmic
27d
Cleared
Nov 09, 2022
Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)
Ophthalmic
37d
Cleared
Mar 23, 2022
Iridex 810 Laser
Ophthalmic
131d
Cleared
Oct 21, 2020
Iridex 810 Laser
Ophthalmic
30d
Cleared
Sep 05, 2018
Iridex TruFocus LIO Premiere
Ophthalmic
72d