The following data is part of a premarket notification filed by Iridex Corp. with the FDA for Iriderm, Model Apex 800.
| Device ID | K992298 |
| 510k Number | K992298 |
| Device Name: | IRIDERM, MODEL APEX 800 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | IRIDEX CORP. 1212 TERRA BELLA AVE. Mountain View, CA 94043 |
| Contact | Brad Renton |
| Correspondent | Brad Renton 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 | 1999-07-08 |
| Decision Date | 1999-12-09 |
| Summary: | summary |