MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI.
Device Facts
| Record ID | K871220 |
|---|---|
| Device Name | MODIFIED CO2 ND:YAG LASER MODEL 880, OB-GYN APPLI. |
| Applicant | Cooper Lasersonics, Inc. |
| Product Code | HHR · Obstetrics/Gynecology |
| Decision Date | Jul 16, 1987 |
| 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.
