21 C.F.R. § 878.4630

Current through October 31, 2024
Section 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.

21 C.F.R. §878.4630