LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K150446
    Device Name
    Erchonia Zerona 6 headed scanner EZ6
    Manufacturer
    ERCHONIA CORPORATION
    Date Cleared
    2015-05-21

    (90 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 6 Headed Scamer (EZ6) device is indicated for use as a non-invasive dermatological aesthetic treatment for the reduction of circumference of hips, waist, thighs and upper abdomen when applied to individuals with body mass index between 25 kg/m2 and 40 kg/m2.

    Device Description

    Not Found

    AI/ML Overview

    The provided document is a 510(k) clearance letter for the Erchonia® Zerona 6 Headed Scanner (EZ6) device. It is a regulatory document and does not contain the detailed study information regarding acceptance criteria, device performance, sample sizes, expert qualifications, or ground truth establishment that you are requesting.

    Therefore, I cannot provide the requested information based on the content of input.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1