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510(k) Data Aggregation

    K Number
    K051681
    Device Name
    DERMILLUME RED, MODEL HR1000
    Manufacturer
    CARE ELECTRONICS, INC.
    Date Cleared
    2005-07-27

    (34 days)

    Product Code
    ILY
    Regulation Number
    890.5500
    Why did this record match?
    Applicant Name (Manufacturer) :

    CARE ELECTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dermillume Red HR1000 infrared lamp is intended for the relaxation of muscles and relief of muscle spasms, temporary relief of minor muscle and joint aches, pains and stiffness, temporary relief of minor pain and stiffness associated with arthritis, and to temporarity increase local blood circulation.
    Device Description
    The Dermillume Red HR1000 lamp is a compact light source that delivers high intensity narrow band red and near infrared light to the skin surface. The light sources are narrow bandwidth LEDs mounted in an array to give even and safe illumination of skin surfaces. The principal parts of the lamp are a light unit, positioning arm and firmware timer to control duration of exposure.
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    K Number
    K043575
    Device Name
    DERMILLUME, MODEL PRO1000
    Manufacturer
    CARE ELECTRONICS, INC.
    Date Cleared
    2005-02-24

    (59 days)

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

    CARE ELECTRONICS, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Dermillume Pro1000 phototherapy lamp is intended for dermatological use by trained licensed practitioners, specifically for the treatment of mild to moderate inflammatory acne vulgaris.
    Device Description
    The Dermillume Pro1000 device is a compact light source that delivers high intensity narrow band blue and red light to the body for the treatment of acne vulgaris. The light sources are narrow wavelength LEDs that supply a spectral output of 414 ± 5 nm (blue) and 633 ± 5 nm (red). The device supplies 20 and 10 mW/cm² for blue and red light, respectively, at 4.6 inches distance from the skin surface. The principal parts of the device are a light unit, positioning arm and firmware timer to control duration of exposure. Additional off-the-shelf electronic devices related to treatment data acquisition and storage may be supplied as user options.
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