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    K Number
    K051113
    Device Name
    QUANTA SYSTEM ETRNA GIOVINEZZA
    Manufacturer
    QUANTA SYSTEM, S.P.A.
    Date Cleared
    2006-01-04

    (247 days)

    Product Code
    GEX
    Regulation Number
    878.4810
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    QUANTA SYSTEM ETRNA GIOVINEZZA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Quanta System Eterna Giovinezza system is indicated for permanent hair reduction, photocoagulation of dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions. It is also indicated for treatment of inflammatory acne (acne vulgaris) and cutaneous lesions, including warts, scars, and striae.

    Device Description

    The Quanta System Eterna Giovinezza system is a pulsed light, wavelength range adjustable system. It provides selectable handpiece aperture sizes for a variety of applications Light emission activation is by foot switch. Overall weight of the system is 110 lbs., and the size is 13.8" x 19" x 40" (LxWxH). Electrical requirement is 110 VAC, 15A, 50 Hz, single phase.

    AI/ML Overview

    The provided text is a 510(k) summary for the Quanta System Eterna Giovinezza system. It does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.

    The 510(k) summary explicitly states under "Nonclinical Performance Data" and "Clinical Performance Data": "none". This indicates that no studies demonstrating performance against specific criteria were submitted as part of this premarket notification.

    Therefore, I cannot provide the requested information, as it is not present in the provided document.

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