LLW · Laser, Neodymium:Yag For Gynecologic Use
Obstetrics/Gynecology · 21 CFR 884.4550 · Class 2
Overview
| Product Code | LLW |
|---|---|
| Device Name | Laser, Neodymium:Yag For Gynecologic Use |
| Regulation | 21 CFR 884.4550 |
| Device Class | Class 2 |
| Review Panel | Obstetrics/Gynecology |
| 3rd-Party Reviewable | Yes |
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.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K850437 | DISPOSABLE LARYNGOSCOPE | Vital Signs, Inc. | Feb 14, 1985 | SESE |
Top Applicants
- Vital Signs, Inc. — 1 clearance
