The following data is part of a premarket notification filed by Iridex Corporation with the FDA for Iridex 810 Laser.
Device ID | K213592 |
510k Number | K213592 |
Device Name: | Iridex 810 Laser |
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 | 2021-11-12 |
Decision Date | 2022-03-23 |