The following data is part of a premarket notification filed by Diomedics, Inc. with the FDA for Diomedics Surgi Light/light Touch Optical Fibers.
| Device ID | K926224 |
| 510k Number | K926224 |
| Device Name: | DIOMEDICS SURGI LIGHT/LIGHT TOUCH OPTICAL FIBERS |
| Classification | Powered Laser Surgical Instrument |
| Applicant | DIOMEDICS, INC. 2828 N. CRESCENT DR. The Woodlands, TX 77381 |
| Contact | Krista Oakes |
| Correspondent | Krista Oakes DIOMEDICS, INC. 2828 N. CRESCENT DR. The Woodlands, TX 77381 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-12-10 |
| Decision Date | 1993-07-22 |