The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Laserpro Cth Holmium Laser System.
| Device ID | K011409 |
| 510k Number | K011409 |
| Device Name: | SLT LASERPRO CTH HOLMIUM LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGICAL LASER TECHNOLOGIES, INC. 147 KEYSTONE DR. Montgomeryville, PA 18936 |
| Contact | Davis Woodward |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2001-05-08 |
| Decision Date | 2001-06-14 |