The following data is part of a premarket notification filed by Iridex Corporation with the FDA for Iridex Cyclog6 Laser System, Micropulse P3 Drive, G-probe(rfid).
| Device ID | K143154 |
| 510k Number | K143154 |
| Device Name: | IRIDEX CycloG6 Laser System, MicroPulse P3 Drive, G-Probe(RFID) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | IRIDEX CORPORATION 1212 TERRA BELLA AVENUE Mountain View, CA 94043 |
| Contact | Paul H Hardiman |
| Correspondent | Kathy Maynor KATHY MAYNOR 26 REBECCA ST Homosassa, FL 34446 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-03 |
| Decision Date | 2015-01-02 |
| Summary: | summary |