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510(k) Data Aggregation

    K Number
    K130519
    Device Name
    PHILIPS UVA (/09) AND PHILIPS UVA-1 (/10) ULTRAVIOLET LAMPS
    Date Cleared
    2013-12-24

    (300 days)

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

    PHILIPS LIGHTING COMPANY

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    These are fluorescent lamps that are designed to produce ultraviolet radiation in the UV-A range. They are not marketed with any additional components or accessories and are to be installed in fixtures designed for treatment of dermatological conditions. The intended function of these UV-A ultraviolet lamps is to be installed in the appropriate devices used for therapy for various skin related disorders.
    Device Description
    Philips UVA Lamp
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