The following data is part of a premarket notification filed by Iridex Corporation with the FDA for Iridex Pascal® 532, Iridex Pascal® 577, Iridex Pascal® (532nm And 577 Nm Models).
| Device ID | K223132 |
| 510k Number | K223132 |
| Device Name: | Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm And 577 Nm Models) |
| Classification | Laser, Ophthalmic |
| Applicant | Iridex Corporation 1212 Terra Bella Ave. Mountain View, CA 94043 |
| Contact | Bill Hyatt |
| Correspondent | Bill Hyatt Iridex Corporation 1212 Terra Bella Ave. Mountain View, CA 94043 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-10-03 |
| Decision Date | 2022-11-09 |