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510(k) Data Aggregation

    K Number
    K134036
    Device Name
    WAVETRONIC 5000 DIGITAL HF SURGICAL UNIT
    Date Cleared
    2015-10-08

    (646 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    LOKTAL MEDICAL ELECTRONICS IND. COM. LTDA- EPP

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Loktal Medical Electronics ind. E com. Ltda EPP - Wavetronic 5000 Digital HF Surgical Unit is intended for resection, ablation, excision of soft tissue, coagulation, and desiccation of soft tissue in patients requiring surgery.
    Device Description
    The Wavetronic 5000 Digital HF Surgical Unit is a non-sterile, reusable electrosurgical generator, which is designed to generate high frequencies (RF) of high voltage and low amperage current, operating at high frequency (4 MHz) to be employed by a variety of electrosurgical procedures. This action is achieved by front panel selection of waveforms and power levels. All selections are effected through push buttons and dials, and lamps, which give the operator feedback of status. The Wavetronic 5000 Digital HF Surgical Unit is an electrosurgical cutting and coagulation device intended to remove tissue and control bleeding by use of high-frequency electrical current. The device has four modes of operation; 1. Cut a basic cutting mode that produces minimal heat. 2. Blend (cut and coagulation) surface coagulation takes place simultaneously with cutting, with wave ratio being approximately 50/50. 3. Coagulation a mode with high lateral heat emission. 4. Bipolar (bipolar coagulation mode) bipolar coagulation mode is intended to remove tissue and control bleeding by use of high-frequency, electrosurgical current. The control unit of the device front panel control provides the user with buttons, enabling to operate the device during therapy, and a display, which shows the set and indicated parameters. The therapeutic parameters can be set or adjusted any time through surgery, and displays the therapeutic method, the set power, and other necessary data required throughout the treatment. The Wavetronic 5000 Digital HF Surgical Unit consists of the following main components: - Wavetronic 5000 Digital high-frequency electromagnetic energy generator - Optional wave selection (cut, blend, coag, bipolar) - Footswitch - Power cable
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