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510(k) Data Aggregation

    K Number
    K143007
    Device Name
    Erchonia Zerona Z6 OTC
    Manufacturer
    ERCHONIA CORPORATION
    Date Cleared
    2015-01-15

    (87 days)

    Product Code
    OLI
    Regulation Number
    878.5400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Erchonia Zerona Z6 OTC

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

    The Zerona® Z6 OTC device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, and thighs.

    Device Description

    Zerona® Z6 OTC

    AI/ML Overview

    The provided document is a 510(k) premarket notification letter from the FDA for the Zerona® Z6 OTC device. It primarily focuses on the substantial equivalence determination and regulatory information.

    This document does not contain the specific details required to answer your request regarding acceptance criteria and a study proving those criteria. The letter refers to indications for use but does not provide a table of acceptance criteria, detailed study results, sample sizes for test/training sets, expert qualifications, adjudication methods, or information about MRMC or standalone performance studies.

    Therefore, I cannot extract the requested information from this document.

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