eCFR Reference Browser

---

title: "21 CFR §874.4490"

source: "https://www.ecfr.gov/current/title-21/section-874.4490"

title_number: "21"

volume_number: "8"

chapter_number: "Unknown"

subchapter_code: "H"

subchapter_subject: "MEDICAL DEVICES"

part_code: "874"

part_subject: "EAR, NOSE, AND THROAT DEVICES"

subpart_code: "E"

subpart_subject: "Surgical Devices"

section_number: "874.4490"

section_subject: "Argon laser for otology, rhinology, and laryngology."

cfr_reference: "21 CFR 874.4490"

title_name: "Title 21"

title_subject: "Food and Drugs"

parts_covered: "Parts 800 to 1299"

revised_date: "Revised as of April 1, 2019"

publication_date: "As of April 1, 2019"

contains_description: "Containing a codification of documents of general applicability and future effect"

publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"

---

(a)Identification. The argon laser device for use in otology, rhinology, and laryngology is an electro-optical device which produces coherent, electromagnetic radiation with principal wavelength peaks of 488 and 514 nanometers. In otology, the device is used for the purpose of coagulating and vaporizing soft and fibrous tissues, including osseous tissue. In rhinology and laryngology, the device is used to coagulate and vaporize soft and fibrous tissues, but not including osseous tissues.

(b)Classification. Class II.

§874.4490 - Argon laser for otology, rhinology, and laryngology.