GL-35 COLPOSCOPIC LASER SYSTEM
Device Facts
| Record ID | K875314 |
|---|---|
| Device Name | GL-35 COLPOSCOPIC LASER SYSTEM |
| Applicant | Laser Engineering, Inc. |
| Product Code | HHR · Obstetrics/Gynecology |
| Decision Date | Aug 5, 1988 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 884.4550 |
| Device Class | Class 2 |
Regulatory Classification
Identification
A gynecologic surgical laser is a continuous wave carbon dioxide laser designed to destroy tissue thermally or to remove tissue by radiant light energy. The device is used only in conjunction with a colposcope as part of a gynecological surgical system. A colposcope is a magnifying lens system used to examine the vagina and cervix.
