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    K Number
    K043164
    Device Name
    PANALIGHT-BLU, MODEL 4175
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Date Cleared
    2004-12-10

    (24 days)

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

    DUSA PHARMACEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The PanaLight-BLU™ Illuminator, Model 4175 is intended to provide phototherapeutic light to the body. The PanaLight-BLU™ is generally indicated to treat dermatological indications. The PanaLight-BLU™ is specifically indicated to treat moderate inflammatory acne vulgaris.
    Device Description
    The PanaLight-BLU™ is a compact light source that delivers a uniform distribution of narrowband blue light to the body with a spectral output at a peak wavelength of 417 +/- 5 nm. The principal parts of the system include the light unit head and floor stand with timer.
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    K Number
    K031805
    Device Name
    BLU-U, MODEL 4170
    Manufacturer
    DUSA PHARMACEUTICALS, INC.
    Date Cleared
    2003-09-09

    (90 days)

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

    DUSA PHARMACEUTICALS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The BLU-U® Blue Light Photodynamic Therapy Illuminator Model 4170 is intended to provide phototherapeutic light to the body. The BLU-U® is generally indicated to treat dermatological indications. The BLU-U® is specifically indicated to treat moderate inflammatory acne vulgaris.
    Device Description
    The BLU-U® 4170 is a compact light source that delivers a uniform distribution of blue light to the body with a spectral output at a peak wavelength of 417 nm and a Full Width at Half Maximum (FWHM) of 30 nm (407 - 437 nm). The principal parts of the system include the light unit and floor stand with timer.
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