21 C.F.R. § 878.4630

Ultraviolet lamp for dermatologic disorders.

Last amended: 2016Year: 2026Length: 59 wordsSubsections: 2Official source

Cite as 21 C.F.R. § 878.4630 (2026)

(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: Ultraviolet lamp for dermatologic disorders. | Justis AI