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510(k) Data Aggregation
K Number
K232992Device Name
10THERMA
Manufacturer
Date Cleared
2023-12-20
(89 days)
Product Code
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Tentech Inc.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended Use
10THERMA indicated for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.
Device Description
10THERMA is a High-Frequency Electrosurgical Unit (ESU). When the high-frequency current generated in the main body is transmitted to the skin through the monopolar electrode connected to the handpiece, heat is generated by the electrical resistance of the skin, and tissue is coagulated with the generated heat.
The 10THERMA is comprised of a main body with a touch LCD monitor, a handpiece, nonsterile mono-polar electrodes (handpiece tips), return pad connector, coupling fluid, cooling gas (cryogen), a power cable, and a foot switch. Among the consisting items, the mono-polar electrodes, return pads, and coupling fluid are single-use and disposable.
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