---
kind: "section"
citation: "21 C.F.R. § 884.4550"
title: "21"
number: "884.4550"
heading: "Gynecologic surgical laser."
url: "https://uscodex.org/cfr/21/884.4550"
---

# §884.4550. Gynecologic surgical laser.

- (a) **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.
- (b) **Classification.** Class II (performance standards).

## Notes

### Authority

Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 360 l , 371.

### Source

Source: 45 FR 12684, Feb. 26, 1980, unless otherwise noted.