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510(k) Data Aggregation

    K Number
    K124064
    Device Name
    YOUNG AGAIN
    Manufacturer
    ESPANSIONE MARKETING SPA
    Date Cleared
    2013-12-19

    (353 days)

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

    ESPANSIONE MARKETING SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Young Again is an over the counter device intended to emit energy in the red and IR region of the spectrum for use in dermatology for treatment of periorbital wrinkles.
    Device Description
    The Young Again is a device which allows emission and treatment with LED light in the RED (634 nm ) and IR (830nm) spectrum. The Young Again devices include a main unit installed on a trolley support, that controls and manages the LED emission through the two facial masks. The facial masks are designed in two versions depending upon the features of the LED installed in the mask: Red or IR The control panel is placed in the main unit with all the circuitry necessary to control the device and the user interacts with the Young Again device through the touch screen panel of the main unit and through a specific software application that allow the precise control of the treatment time.
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    K Number
    K070494
    Device Name
    EPI-C PLUS
    Manufacturer
    ESPANSIONE MARKETING SPA
    Date Cleared
    2007-05-01

    (70 days)

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

    ESPANSIONE MARKETING SPA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    This product is intended for dermatological use by physicians and healthcare professionals for the following: - Removal of unwanted hair in all skin types (from 570- to 1200mm filter) . - Treatment of vascular and benign pigmented lesions, cutaneous lessons including . warts, scars, striae and facial and leg veins (from 550 to 1200mm filter). - Treatment of Acne (from 390 to 1200nm filter) .
    Device Description
    The device is designed and manufactured to emit a high intensity pulsed light applied to the patient's skin. The light is emitted by a quick discharge of capacitors on a xenon flash lamp with a high energy. The lamp delivers a wavelength in the band of 390-1200nm. The three principal parts of this system are: - The Principal Unit which contain all circuitry to control the device. - The Handpiece contains circuitry to control the Lamp & Filter group. - The Lamp & Filter group is a removable box that contains Xenon Flash Lamp and Filter mounted on to the handpiece.
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