21 C.F.R. § 878.4630 Ultraviolet lamp for dermatologic disorders.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 878—GENERAL AND PLASTIC SURGERY DEVICES
Subpart E—Surgical Devices
§ 878.4630 Ultraviolet lamp for dermatologic disorders.