K875314 is an FDA 510(k) clearance for the GL-35 COLPOSCOPIC LASER SYSTEM. This device is classified as a Laser, Surgical, Gynecologic (Class II — Special Controls, product code HHR).
Submitted by Laser Engineering, Inc. (Milford, US). The FDA issued a Cleared decision on August 5, 1988, 220 days after receiving the submission on December 29, 1987.
This device falls under the Obstetrics & Gynecology FDA review panel. Regulated under 21 CFR 884.4550.
| 510(k) Number | K875314 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 29, 1987 |
| Decision Date | August 05, 1988 |
| Days to Decision | 220 days |
| Submission Type | Traditional |
| Review Panel | Obstetrics & Gynecology (OB) |
| Summary | — |
| Product Code | HHR — Laser, Surgical, Gynecologic |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 884.4550 |