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510(k) Data Aggregation

    K Number
    K062991
    Device Name
    GENTLEWAVES CONSUMER LED PHOTOMODULATION DEVICE
    Manufacturer
    LIGHT BIOSCIENCE, LLC
    Date Cleared
    2008-02-15

    (504 days)

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

    LIGHT BIOSCIENCE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GentleWaves Consumer LED Photomodulation Device is intended/indicated for over-the-counter use in the treatment of periorbital wrinkles and rhytides.
    Device Description
    The GentleWaves Consumer is a hand-held device consisting of a low intensity light emitting diode (LED) lamp placed in contact with the skin at a fixed distance determined by its lens cover. The device components include an LED array, a lens, a handpiece, three circuit boards, a power supply enclosure and power supply.
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    K Number
    K031425
    Device Name
    GENTLEWAVES LED PHOTOMODULATION DEVICE
    Manufacturer
    LIGHT BIOSCIENCE, LLC
    Date Cleared
    2004-12-15

    (590 days)

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

    LIGHT BIOSCIENCE, LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The GentleWaves LED Photomodulation Device is indicated/intended for use in the treatment of periorbital wrinkles and rhytides.
    Device Description
    Not Found
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