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510(k) Data Aggregation

    K Number
    K051956
    Device Name
    DR. OPPEL ST-501
    Date Cleared
    2005-09-08

    (51 days)

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

    SOMETECH INCORPORATED

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    Dr. OPPEL ST-501 is intended for the removal and destruction of skin legions and the coagulation of tissue. Non-sterile and reusable electrodes are used in conjunction with an electrosurgical handpiece and generator.
    Device Description
    Dr. OPPEL ST-501 is a electrosurgical unit using high frequency current to cut and/or coagulate tissue. It consists of Electrosurgical Unit generator, Handpiece, Electrodes, a cable for disposable patient plate and foot switch. It is a compact source of high power RF energy to be employed for a variety of radiosurgery procedures. This action is achieved by front panel selection of power level and time. All selection is effected through push buttons and lamps that give the operator feedback of status. The final output power control is made through foot and/or hand switches. Both Monopolar and Bipolar electrodes are provided. Monopolar electrodes have needle, ball, loop and blade types. Electrodes are supplied non-sterile and reusable.
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