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510(k) Data Aggregation

    K Number
    K120257
    Device Name
    MLS, ZERONA-AD
    Manufacturer
    ERCHONIA MEDICAL, INC.
    Date Cleared
    2012-05-14

    (108 days)

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

    MLS, ZERONA-AD

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

    The Erchonia® MLS, Zerona™ is indicated for non-invasive dermatological aesthetic treatment for the reduction of the circumference of the upper arms.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a medical device called Erchonia® MLS, Zerona™. It primarily communicates the FDA's decision regarding substantial equivalence and regulatory compliance. It does not contain information about acceptance criteria for a study, nor does it describe a study's methodology or results in detail. Therefore, I cannot extract the information required to answer your request.

    The letter states the "Indications for Use" for the device, which is "non-invasive dermatological aesthetic treatment for the reduction of the circumference of the upper arms." However, it does not provide acceptance criteria or a study proving that the device meets such criteria.

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