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510(k) Data Aggregation

    K Number
    K070870
    Device Name
    SKIN CARE LIGHT
    Date Cleared
    2007-10-10

    (195 days)

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

    TRANSVERSE INDUSTRIES CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Skin Care Light is intended to provide phototherapeutic light to the face. It is used to treat dermatological conditions by exposing the surface of the skin to the blue spectrum. It is specifically indicated to treat moderate inflammatory acne vulgaris.
    Device Description
    Skin Care Light is a lamp intended to treat dermatological conditions by emitting visible light in blue and/or red.The energy intensity are 4,8,12mW/c m².The system includes a spectral band light source and some controlling keys to select light.It also includes mechanical fixture for holding the light source at an adjustable distance and direction related to the skin treatment area,an electronic unit to control the duration,it will automatically shut off after 15 minutes.
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