[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: 21CFR878.4630]

[Page 385]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 878--GENERAL AND PLASTIC SURGERY DEVICES--Table of Contents
 
                       Subpart E--Surgical Devices
 
Sec. 878.4630  Ultraviolet lamp for dermatologic disorders.

    (a) Identification. An ultraviolet lamp for dermatologic disorders 
is a device (including a fixture) intended to provide ultraviolet 
radiation of the body to photoactivate a drug in the treatment of a 
dermatologic disorder if the labeling of the drug intended for use with 
the device bears adequate directions for the device's use with that 
drug.
    (b) Classification. Class II.