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510(k) Data Aggregation
K Number
K181455Device Name
ProSun sunlamp products, Luxura sunlamp products
Manufacturer
ProSun International LLC
Date Cleared
2018-09-10
(98 days)
Product Code
LEJ
Regulation Number
878.4635Why did this record match?
Applicant Name (Manufacturer) :
ProSun International LLC
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
Tanning Bed Systems are intended to provide tanning of the human skin.
Device Description
The primary technical components of sunlamp products are whole body tanning devices consisting of a mechanical frame with Ultraviolet (UV) lamps providing an artificial source of UV radiation. The UV light is intended for irradiation of the human body to induce skin tanning. The user of the proposed devices device either lies in the horizontal tanning bed or stands in the vertical tanning booth.
Skin tanning varies with skin type and as the UV sources intensities with characteristic UV-A and UV-B proportions result in cosmetic tanning of the human skin.
The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but fades more rapidly. The UV-B radiation is primarily responsible for more longterm tanning results.
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