The following data is part of a premarket notification filed by Iriderm Div. with the FDA for Iris Oculight(r) Slx.
| Device ID | K913430 |
| 510k Number | K913430 |
| Device Name: | IRIS OCULIGHT(R) SLX |
| Classification | Powered Laser Surgical Instrument |
| Applicant | IRIDERM DIV. 340 PIONEER WAY Mountain View, CA 94041 -1506 |
| Contact | A Boutacoff |
| Correspondent | A Boutacoff IRIDERM DIV. 340 PIONEER WAY Mountain View, CA 94041 -1506 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-08-01 |
| Decision Date | 1991-11-15 |