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510(k) Data Aggregation

    K Number
    K082232
    Device Name
    EVIS MD PLANTIUM BLUE
    Manufacturer
    AGELESS BEAUTY CORPORATION
    Date Cleared
    2008-10-15

    (69 days)

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

    AGELESS BEAUTY CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Evis MD Platinum Blue Light Therapy device is intended to provide light to the body. Generally indicated to treat dermatological conditions and specifically indicated to treat mild to moderate inflammatory acne vulgaris.
    Device Description
    The Evis MD Platinum Blue Light Therapy device that utilizes Light Emitting Diodes to provide LED light to the body. The hand hold device contains the power supplies and a built in timed sound signaling with auto shut off. The device delivers the light to the skin as it moves over the skin. The wavelength for Blue is 41.5 +/- 5 nm.
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    K Number
    K082247
    Device Name
    EVIS MD PLATINUM RED LIGHT THERAPY
    Manufacturer
    AGELESS BEAUTY CORPORATION
    Date Cleared
    2008-10-08

    (61 days)

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

    AGELESS BEAUTY CORPORATION

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Evis MD Platinum Red Light Therapy device is intended to provide light to the body. Generally indicated to dermatology use for the treatment of superficial, benign vascular and pigmented lesions "such as but not limited to solar lentigines, sun spots, liver spots and age spots".
    Device Description
    The Evis MD Platinum Red Light Therapy device that utilizes Light Emitting Diodes to provide LED light to the body. The hand held device contains the power supplies and a built in audible indicator with auto shut off. The device delivers the light to the skin as it moves over the skin. The wavelength for red is 630 +/- 5 nanometer. Evis MD Platinum Red does not use any software.
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