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21 CFR 874.4490

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

United States · 21 CFR — Food and Drugs · Status: effective

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21 CFR 874.4490, § 874.4490 Argon laser for otology, rhinology, and laryngology, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90242
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(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.

Legislative history

This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.