The following data is part of a premarket notification filed by Laser Engineering, Inc. with the FDA for Gl-35 Colposcopic Laser System.
| Device ID | K875314 |
| 510k Number | K875314 |
| Device Name: | GL-35 COLPOSCOPIC LASER SYSTEM |
| Classification | Laser, Surgical, Gynecologic |
| Applicant | LASER ENGINEERING, INC. 113 CEDAR ST. Milford, MA 01757 |
| Contact | Robert I Rudko |
| Correspondent | Robert I Rudko LASER ENGINEERING, INC. 113 CEDAR ST. Milford, MA 01757 |
| Product Code | HHR |
| CFR Regulation Number | 884.4550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-12-29 |
| Decision Date | 1988-08-05 |