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510(k) Data Aggregation

    K Number
    K043402
    Device Name
    THERMAGE THERMACOOL SYSTEM
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2005-01-14

    (35 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K040135,K033942,K021402,K013639,K013034,K003183,K000944
    Predicate For
    K072849,K082956,K090580
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Thermage ThermaCool System is indicated for use in:

    • The Thermage ThermaCool System is indicated for use in . and General Surgical procedures for Dermatologic electrocoagulation and hemostasis.
    • Non-invasive treatment of periorbital wrinkles and rhytids. .
    • Non-invasive treatment of facial wrinkles and rhytids. .
    Device Description

    The Thermage ThermaCool System consists of the following components:

    • ThermaCool System ●
    • Handpiece Assembly (consisting of Handpiece and Treatment Tip) .
    • Accessories: Coolant Canister, Coupling Fluid, Return Pad and Skin . Marking Paper
    • Accessory cables and tubing .
    • Optional footswitch component .
    AI/ML Overview

    The provided document is a 510(k) Safety Summary for the Thermage ThermaCool System Treatment Tip, seeking substantial equivalence to predicate devices. It does not contain information about acceptance criteria or a study proving device performance against acceptance criteria.

    The document focuses on:

    • Identifying the device and its classification.
    • Listing predicate devices.
    • Describing the device components and its intended uses.
    • Stating that its technical characteristics are "substantially equivalent" to cleared predicate devices.
    • Confirming FDA's substantial equivalence determination.

    Therefore, I cannot provide the requested information, as it is not present in the given text.

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