The following data is part of a premarket notification filed by Iridex Corp. with the FDA for Apex 800 Laser System, Model Apex 800.
| Device ID | K020849 |
| 510k Number | K020849 |
| Device Name: | APEX 800 LASER SYSTEM, MODEL APEX 800 |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-03-15 |
| Decision Date | 2002-05-20 |
| Summary: | summary |