The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for Slt Cl Md Contact Laser System.
| Device ID | K972548 |
| 510k Number | K972548 |
| Device Name: | SLT CL MD CONTACT LASER SYSTEM |
| Classification | Powered Laser Surgical Instrument |
| Applicant | SURGICAL LASER TECHNOLOGIES, INC. 147 KEYSTONE DR. Montgomeryville, PA 18936 |
| Contact | Monica Ferrante |
| Correspondent | Monica Ferrante SURGICAL LASER TECHNOLOGIES, INC. 147 KEYSTONE DR. Montgomeryville, PA 18936 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-08 |
| Decision Date | 1998-04-21 |
| Summary: | summary |