HAND/FOOT UVA 624-218

K872605 · National Biological Corp. · FTC · Jul 24, 1987 · General, Plastic Surgery

Device Facts

Record IDK872605
Device NameHAND/FOOT UVA 624-218
ApplicantNational Biological Corp.
Product CodeFTC · General, Plastic Surgery
Decision DateJul 24, 1987
DecisionSESE
Submission TypeTraditional
Regulation21 CFR 878.4630
Device ClassClass 2

Regulatory Classification

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.

Innolitics
510(k) Summary
Decision Summary
Classification Order
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