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510(k) Data Aggregation

    K Number
    K152364
    Device Name
    uwe sun tanning beds/booths P90, iBED EVG, iSUN HP, SILVERBULLET SE, LOTUS
    Manufacturer
    Date Cleared
    2016-04-14

    (237 days)

    Product Code
    Regulation Number
    878.4635
    Why did this record match?
    Applicant Name (Manufacturer) :

    PC Marketing, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Intended to provide ultraviolet light to tan the skin.
    Device Description
    The uwe sun tanning beds/booths consist of several essential parts. These parts differ between the bed and the booth models. The beds consist of a lying area and a canopy. The booth consists of a cabin and a door. Both sunlamp products contain the same electronic components like the main board and the relay board, fans, lamps etc. The most significant differences are the decorating design elements and the implemented features like "Body Mist" and "Aroma". These constitute the several looks of the beds and booths. The primary technical components of a tanning device are an artificial source of UV radiation, a variety of filters and reflectors as well as a mechanical structure with a defined active surface. Different tanning results can be achieved in varying strength tanning devices. This is due to the different strength UV lamps and the different UV-A and UV-B proportions of the UV radiation. The UV-A proportion primarily generates a superficial tan, which appears rapidly and is intensive but also fades more rapidly, the UV-B radiation is primarily responsible for more long-term tanning results. The disadvantage of the UV-B radiation is that the tan does not become visible until one or two days after visiting the tanning salon. Therefore, the appropriate tanning device is to be selected depending on the desired tanning goal.
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