[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2003]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR874.4490]

[Page 354]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 874--EAR, NOSE, AND THROAT DEVICES--Table of Contents
 
                       Subpart E--Surgical Devices
 
Sec. 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]