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    K Number
    K091125
    Device Name
    CLEARWAVE PHOTOTHERAPY SYSTEM FOR ACNE, MODEL: CWST2
    Manufacturer
    VERILUX
    Date Cleared
    2010-09-03

    (504 days)

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

    VERILUX

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The ClearWave Phototherapy System for Acne provides phototherapeutic blue light to treat mild to moderate inflammatory acne.
    Device Description
    The Clear Wave® Phototherapy System for Acne is a hand held light device which emits a low intensity of blue light at a wavelength of 414 ± 10 nm in the visible range of the spectrum. The head is programmed with a timed treatment cycle. The light modules are contained in the changeable head of a hand held device. The Clear Wave® Phototherapy System for Acne is small and light weight which allows for easy handling and mobility.
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