21 CFR § 878.4630 General and Plastic Surgery Devices

§ 878.4630 Ultraviolet lamp for dermatologic disorders.

Current through Sep 8, 2026 · Read all of Part 878

(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.

← § 878.4590 Focused ultrasound stimulator system for aesthetic use.§ 878.4635 Sunlamp products and ultraviolet lamps intended for use in sunlamp products. →