21 CFR 878.4630
§ 878.4630 Ultraviolet lamp for dermatologic disorders.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 878.4630, § 878.4630 Ultraviolet lamp for dermatologic disorders, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/90444
- Permanent ID
ys:prov:90444@1- SHA-256
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.