The following data is part of a premarket notification filed by Iridex Corporation with the FDA for Iridex Cyclo G6 Laser System, G-probe Illuminate.
| Device ID | K162416 |
| 510k Number | K162416 |
| Device Name: | IRIDEX Cyclo G6 Laser System, G-Probe Illuminate |
| Classification | Powered Laser Surgical Instrument |
| Applicant | IRIDEX CORPORATION 1212 TERRA BELLA AVENUE Mountain View, CA 94043 |
| Contact | Kathy Maynor |
| Correspondent | Kathy Maynor IRIDEX CORPORATION 1212 TERRA BELLA AVENUE Mountain View, CA 94043 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-08-30 |
| Decision Date | 2016-09-29 |
| Summary: | summary |