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510(k) Data Aggregation

    K Number
    K121695
    Device Name
    ERCHONIA ZERONA
    Manufacturer
    ERCHONIA CORPORATION
    Date Cleared
    2012-08-23

    (77 days)

    Product Code
    OLI
    Regulation Number
    878.5400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Erchonia Zerona is indicated for use as a non-invasive dermatological aesthetic treatment as an adjunct for individuals intending to undergo liposuction procedures for the reduction of circumference of hips, waist, and thighs.

    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for the Erchonia Zerona device. It states that the device is substantially equivalent to a legally marketed predicate device.

    Crucially, this document does not contain any information about acceptance criteria, device performance studies, sample sizes for test or training sets, ground truth establishment, expert qualifications, or adjudication methods.

    The letter is a regulatory approval, not a scientific study report. It confirms the device's clearance for marketing based on its substantial equivalence to another device and its stated Indications for Use.

    Therefore, I cannot provide the requested information from the given input.

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