SUNTAN CONNECTIONS BAHAMA SUN-BOOTH

K844870 · Suntan Connection · FTC · Jan 9, 1985 · General, Plastic Surgery

Device Facts

Record IDK844870
Device NameSUNTAN CONNECTIONS BAHAMA SUN-BOOTH
ApplicantSuntan Connection
Product CodeFTC · General, Plastic Surgery
Decision DateJan 9, 1985
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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