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510(k) Data Aggregation

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

    (300 days)

    Product Code
    FTC
    Regulation Number
    878.4630
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification FDA letter regarding a Philips UVA Lamp. It does not contain information about the acceptance criteria and the study that proves the device meets the acceptance criteria, as it is a regulatory document and not a scientific study report. Therefore, I cannot extract the requested details from this input.

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