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510(k) Data Aggregation
K Number
K051956Device Name
DR. OPPEL ST-501
Manufacturer
Date Cleared
2005-09-08
(51 days)
Product Code
Regulation Number
878.4400Why 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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