SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE
Device Facts
| Record ID | K862861 |
|---|---|
| Device Name | SURGICAL CARBON DIOXIDE SYS. MODEL 10-C OB-GYN USE |
| Applicant | Directed Energy, Inc. |
| Product Code | HHR · Obstetrics/Gynecology |
| Decision Date | Oct 27, 1986 |
| 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.
