[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: 21CFR878.4635]

[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. 878.4635  Ultraviolet lamp for tanning.

    (a) Identification. An ultraviolet lamp for tanning is a device that 
is a lamp (including a fixture) intended to provide ultraviolet 
radiation to tan the skin. See Sec. 1040.20 of this chapter.
    (b) Classification. Class I (general controls). The device is exempt 
from the premarket notification procedures in subpart E of part 807 of 
this chapter, subject to the limitations in Sec. 878.9.

[55 FR 48440, Nov. 20, 1990, as amended at 59 FR 63010, Dec. 7, 1994; 66 
FR 38803, July 25, 2001]