The following data is part of a premarket notification filed by Iridex Corp. with the FDA for Oculight Sl/slx.
| Device ID | K020374 |
| 510k Number | K020374 |
| Device Name: | OCULIGHT SL/SLX |
| Classification | Laser, Ophthalmic |
| Applicant | IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View, CA 94043 |
| Contact | John D'angelo |
| Correspondent | John D'angelo 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 | 2002-02-04 |
| Decision Date | 2002-05-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00813125016319 | K020374 | 000 |
| 00813125016302 | K020374 | 000 |
| 00813125016296 | K020374 | 000 |
| 00813125016289 | K020374 | 000 |
| 00813125010935 | K020374 | 000 |
| 00813125010645 | K020374 | 000 |
| 00813125010591 | K020374 | 000 |
| 00813125010584 | K020374 | 000 |