21 CFR § 884.4550 - Gynecologic surgical laser.

---
identifier: "/us/cfr/t21/s884.4550"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 884.4550 - Gynecologic surgical laser."
title_number: 21
title_name: "Food and Drugs"
section_number: "884.4550"
section_name: "Gynecologic surgical laser."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "884"
part_name: "OBSTETRICAL AND GYNECOLOGICAL DEVICES"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 351, 360, 360c, 360e, 360j, 360, 371."
regulatory_source: "45 FR 12684, Feb. 26, 1980, unless otherwise noted."
cfr_part: "884"
---


# 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).