The following data is part of a premarket notification filed by Iriderm Div. with the FDA for Diolite 532.
| Device ID | K964074 |
| 510k Number | K964074 |
| Device Name: | DIOLITE 532 |
| Classification | Powered Laser Surgical Instrument |
| 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 | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-10-11 |
| Decision Date | 1997-04-01 |
| Summary: | summary |