The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Diffuser Fiber.
| Device ID | K010041 |
| 510k Number | K010041 |
| Device Name: | SLT DIFFUSER FIBER |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGICAL LASER TECHNOLOGIES, INC. 147 KEYSTONE DR. Montgomeryville, PA 18936 |
| Contact | Davis Woodward |
| Correspondent | Robert Mosenkis CITECH 5200 BUTLER PIKE Plymouth Meeting, PA 19462 -1298 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-01-05 |
| Decision Date | 2001-03-07 |