878.4630 Ultraviolet lamp for dermatologic disorders.§ 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.