The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Sidefiring Refractive Fiber (high Power Density Fiber).
| Device ID | K950819 |
| 510k Number | K950819 |
| Device Name: | SLT SIDEFIRING REFRACTIVE FIBER (HIGH POWER DENSITY FIBER) |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGICAL LASER TECHNOLOGIES, INC. 200 CRESSON BLVD. P.O.BOX 880 Oaks, PA 19456 -0880 |
| Contact | Richard G Jones |
| Correspondent | Richard G Jones SURGICAL LASER TECHNOLOGIES, INC. 200 CRESSON BLVD. P.O.BOX 880 Oaks, PA 19456 -0880 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-02-23 |
| Decision Date | 1995-04-18 |