The following data is part of a premarket notification filed by Iriderm Div. with the FDA for Diopexy Probe.
| Device ID | K960522 |
| 510k Number | K960522 |
| Device Name: | DIOPEXY PROBE |
| Classification | Laser, Ophthalmic |
| Applicant | IRIDERM DIV. 340 PIONEER WAY Mountain View, CA 94041 -1506 |
| Contact | Theodore A Boutacoff |
| Correspondent | Theodore A Boutacoff IRIDERM DIV. 340 PIONEER WAY Mountain View, CA 94041 -1506 |
| Product Code | HQF |
| Subsequent Product Code | GEX |
| Subsequent Product Code | HQB |
| CFR Regulation Number | 886.4390 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-02-06 |
| Decision Date | 1996-07-19 |
| Summary: | summary |