The following data is part of a premarket notification filed by Surgical Laser Technologies, Inc. with the FDA for S.l.t. Contact Laser System.
| Device ID | K855100 |
| 510k Number | K855100 |
| Device Name: | S.L.T. CONTACT LASER SYSTEM |
| Classification | Laser For Gastro-urology Use |
| Applicant | SURGICAL LASER TECHNOLOGIES, INC. 250 E 5TH ST. SUITE 1500 COLUMBIA PLAZA BLDG. Cincinnati, OH 45202 |
| Contact | Richard L Studer |
| Correspondent | Richard L Studer SURGICAL LASER TECHNOLOGIES, INC. 250 E 5TH ST. SUITE 1500 COLUMBIA PLAZA BLDG. Cincinnati, OH 45202 |
| Product Code | LNK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-23 |
| Decision Date | 1986-02-26 |