21 CFR 884.4550 — Laser, Surgical, Gynecologic
Obstetrics/Gynecology (OB) · Part 884 Subpart E—Obstetrical and Gynecological Surgical Devices · § 884.4550
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).
Product Codes
| Product Code | Device Name | Class | Devices | Attributes |
|---|---|---|---|---|
| HHR | Laser, Surgical, Gynecologic | 2 | 48 | 3rd Party |
| LLW | Laser, Neodymium:Yag For Gynecologic Use | 2 | 1 | 3rd Party |
