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510(k) Data Aggregation

    K Number
    K181062
    Device Name
    Ultra Facial Toning System
    Manufacturer
    Micro Current Technology, Inc.
    Date Cleared
    2018-07-18

    (86 days)

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

    Ultra Facial Toning System

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

    The Ultra Facial Toning System is intended to stimulate the face. The device is intended for cosmetic use.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a device called "Ultra Facial Toning System." It is a regulatory document addressing the substantial equivalence of the device to existing predicate devices. It does not contain any information about acceptance criteria or the study that proves the device meets those criteria.

    Specifically, the document:

    • Confirms K181062 as the premarket notification number.
    • States the Trade/Device Name: Ultra Facial Toning System.
    • Identifies the Regulation Number and Name for Transcutaneous Electrical Nerve Stimulator For Pain Relief.
    • Classifies the device as Class II with Product Code NFO.
    • Declares the device substantially equivalent for its stated indications for use.
    • Outlines general controls provisions and other regulatory requirements.
    • Provides contact information for various FDA departments.
    • Details the "Indications for Use" which states: "The Ultra Facial Toning System is intended to stimulate the face. The device is intended for cosmetic use."
    • Notes it is a Prescription Use device.

    Therefore, it is not possible to describe acceptance criteria or a study proving the device meets them based on the provided text, as this information is not present in the document.

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