CARBON DIOXIDE LASER ML 825
Device Facts
| Record ID | K833528 |
|---|---|
| Device Name | CARBON DIOXIDE LASER ML 825 |
| Applicant | Merrimack Laboratories |
| Product Code | HHR · Obstetrics/Gynecology |
| Decision Date | Feb 19, 1985 |
| 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.
