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510(k) Data Aggregation

    K Number
    K233525
    Device Name
    MF SC Facial Toning System
    Manufacturer
    Micro Current Technology, Inc.
    Date Cleared
    2023-11-24

    (23 days)

    Product Code
    NFO
    Regulation Number
    882.5890
    Type
    Traditional
    Panel
    Neurology
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MF SC Facial Toning System

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

    The MF SC Facial Toning System is intended to stimulate the face. The device is indicated for over the counter cosmetic use.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the "MF SC Facial Toning System." The document is an FDA 510(k) clearance letter, which primarily addresses regulatory aspects like substantial equivalence to predicate devices and adherence to general controls provisions. It does not include details about specific performance studies or their results.

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