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510(k) Data Aggregation

    K Number
    K073477
    Device Name
    PHOTONOVA FAMILY OF PULSED LIGHT SYSTEMS
    Manufacturer
    PHOTONOVA OFSWEDEN AB
    Date Cleared
    2008-05-09

    (150 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    PHOTONOVA OFSWEDEN AB

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PhotoNova Family of Pulsed Light Systems is indicated for the following: • The removal of unwanted hair form all skin types and to effect stable long-term or permanent hair reduction • The treatment of benign pigmented lesions, including lentigines, nevi, melasma and café-au-lait • The treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, ttelangiectasias, rosacea, facial and leg veins • Treatment of inflammatory acne (acne vulgaris)
    Device Description
    The Photonova Pulsed Light Systems delivers pulsed light at wavelengths starting at 515 nanometers. The device consists of three interconnected sections: The cabinet which houses the power supply, the cooling system and the microcontroller, the umbilical to the handpiece, and the handpiece, which houses the waveguide
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