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510(k) Data Aggregation

    K Number
    K151674
    Device Name
    Ultraviolet Sun Tanning Lamp
    Manufacturer
    G.I.E.- GESELLSCHAFT FUR LICHTTECHNISCHE ERZEUGNISSE MBH
    Date Cleared
    2015-10-20

    (120 days)

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

    G.I.E.- GESELLSCHAFT FUR LICHTTECHNISCHE ERZEUGNISSE MBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These devices are UV-B and UV-A lamps intended to provide ultraviolet radiation to tan the skin.
    Device Description
    These UV Tanning lamps are medium pressure halide lamps with a quartz glass bulb, filled with metal halide, mercury and argon gas, equipped with 2 electrodes and a socket to provide ultraviolet radiation to induce skin tanning at any part of the living human body.
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