U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 28, 2025

Searching within: All TitlesTitle 21Chapter IPart 878Subpart E - Subpart E—Surgical Devices
Exit search mode at current location
§ 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.