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510(k) Data Aggregation

    K Number
    K181455
    Device Name
    ProSun sunlamp products, Luxura sunlamp products
    Manufacturer
    ProSun International LLC
    Date Cleared
    2018-09-10

    (98 days)

    Product Code
    LEJ
    Regulation Number
    878.4635
    Why 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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