Title 21: Food and Drugs
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/ PART 874 - EAR, NOSE, AND THROAT DEVICES
/ Subpart E - Surgical Devices / § 874.4490 Argon laser for otology, rhinology, and laryngology.
§ 874.4490 Argon laser for otology, rhinology, and laryngology.
(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.