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510(k) Data Aggregation

    K Number
    K000944
    Device Name
    THERMAGE THERMACOOL SYSTEM
    Manufacturer
    THERMAGE, INC.
    Date Cleared
    2000-07-19

    (118 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    N/A
    Predicate For
    K013034,K013639,K021149,K021402,K022266,K033942,K043402,K072261,K082962,K130689
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Thermage ThermaCool System is indicated for use in Dermatologic and General Surgical procedures for electrocoagulation and hemostasis.

    Device Description

    The Thermage ThermaCool System consists of the following components.

    • RF Generator .
      Handpiece Connection Module .
    • Cooling Module .
    • Handpiece Assembly (consisting of Handpiece and RF Electrode Insert), and .
      Accessory cables and tubing. .
      The Handpiece Assembly connects to the distal end of the Handpiece Connection Module and to the distal end of the Cooling Module. The proximal end of the Handpiece Connection Module and the proximal end of the Cooling Module connect to the RF Generator.
      The Thermage ThermaCool System is monopolar. Commercially available dispersive electrodes (return pads) are required for operation.
    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. The provided text is a 510(k) premarket notification summary for the Thermage ThermaCool System, focusing on its substantial equivalence to predicate devices for its intended use in electrocoagulation and hemostasis. It describes the device, its classification, and declares its substantial equivalence based on design, principle of operation, materials, and intended use.

    Therefore, I cannot populate the table or answer the specific questions regarding acceptance criteria, study design, sample sizes, ground truth, or expert qualifications, as this information is not present in the provided text.

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