The following data is part of a premarket notification filed by Iridex Corp. with the FDA for Iris Medical Iq 810 Photocoagulator.
| Device ID | K040209 |
| 510k Number | K040209 |
| Device Name: | IRIS MEDICAL IQ 810 PHOTOCOAGULATOR |
| Classification | Laser, Ophthalmic |
| Applicant | IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View, CA 94043 |
| Contact | John Jossy |
| Correspondent | John Jossy IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View, CA 94043 |
| Product Code | HQF |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-01-30 |
| Decision Date | 2004-09-20 |
| Summary: | summary |