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510(k) Data Aggregation
K Number
K171094Device Name
Thermi Reusable Non-invasive RF Electrode
Manufacturer
ThermGen, L.L.C
Date Cleared
2017-05-08
(26 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ThermGen, L.L.C
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thermi Reusable Non-Invasive RF Electrodes used with the Thermi RF Generator System are indicated:
- for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
Device Description
The Thermi Reusable Non-Invasive RF Electrode is a transcutaneous thermal/coagulation electrode designed to provide finely-controlled radiofrequency (RF) energy in combination with Thermi RF Generator. They are not intended to function with non-Thermi branded products.
The electrode connects to a Thermi RF Generator and requires the use of a grounding pad to complete the circuit. The Electrode delivers the RF signal from the generator to the electrode active tip. From the active tip, the RF signal triggers the tissue molecules to vibrate resulting in the formation of heat.
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