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510(k) Data Aggregation

    K Number
    K251988

    Validate with FDA (Live)

    Device Name
    Boston iFace (Boston iFace)
    Manufacturer
    Boston Aesthetics, Inc.
    Date Cleared
    2026-01-12

    (199 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Age Range
    All
    Reference & Predicate Devices
    K241832,K222556,K211639
    Predicate For
    N/A
    Why did this record match?
    Reference Devices :

    K241832, K222556

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

    The Boston iFace is intended to be used for heating to rise tissue temperature, which is used for selected medical conditions, such as temporary relief of pain, muscle spasms, and promotion of local circulation.

    Device Description

    The Boston iFace is mainly composed of a host, a footswitch, a handpiece, a hand swtich, a power cord, tip connectors, tips and a trolley.

    The Boston iFace is a state-of-the-art radiofrequency device that enables the application of therapy by a high-frequency field. The control unit of the system is equipped with a large color touch screen that significantly facilitates the use of the device. The on-screen information guides the user step-by-step through the entire therapy procedure. The therapeutic parameters are easily set using the touch screen of the device. During the therapy the device displays information about the applied therapy type, remaining therapy time and main therapy parameters on the screen. For easier control, the hand-pieces are equipped with buttons, enabling operation of the device during therapy.

    AI/ML Overview

    N/A

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