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e-CFR data is current as of March 4, 2021

Title 21Chapter ISubchapter HPart 874Subpart E → §874.4490


Title 21: Food and Drugs
PART 874—EAR, NOSE, AND THROAT DEVICES
Subpart E—Surgical Devices


§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.

[58 FR 29534, May 21, 1993]

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