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510(k) Data Aggregation

    K Number
    K210004
    Device Name
    i8 Tanning Booth
    Manufacturer
    Ultrasun International B.V.
    Date Cleared
    2021-12-10

    (340 days)

    Product Code
    FTC, CLA, LEJ
    Regulation Number
    878.4630
    Why did this record match?
    Applicant Name (Manufacturer) :

    Ultrasun International B.V.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The i8 tanning booth is an over-the-counter tanning device emitting ultraviolet light in the UVB and UVA region of the spectrum for the tanning of the human skin of an adult person.
    Device Description
    Ultrasun International B.V. i8 Sun Tanning Booth is a tanning device consisting of a mechanical structure equipped with artificial light sources using ultraviolet light technology, which produces ultraviolet radiation within the UVA and UVB ranges. The UV light is intended to induce skin tanning. The user stands within the unit.
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