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510(k) Data Aggregation

    K Number
    K180581
    Device Name
    UV Lamps for Sunlamp Products
    Manufacturer
    Feilo Sylvania Germany GmbH
    Date Cleared
    2018-06-22

    (113 days)

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

    Feilo Sylvania Germany GmbH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This ultraviolet lamp is intended for use in sunlamp products for tanning of human skin.
    Device Description
    The component ultraviolet lamp model family or part numbers are for use in sunlamp products to tan human skin. They fall into a generic class of UV lamps that have the same basic technological features, characteristics, except for power rating, diameter and length, with the exact same intended use. The UV sunlamp model family are for tanning human skin use. They vary in brand ID and unique lamp ratings accordingly. These sunlamps fit into a wavelength range of 200-710nm and operate from the end product ballast supply. There are individual component sunlamps listed in the exhibit page. They are classified as low pressure, mercury rare gas discharge devices and generally have the same construction and technical principals of operation as that of a common fluorescent lamp. The UV lamps have a tubular glass envelope with internal surface coated with fluorescent phosphor. The sealed lamps include the composition and electrical means to activate the UV light within the wavelength specification. The construction is controlled by production procedures and test methods defined in the QMS. The UV radiation is controlled by these methods to assure safe use.
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