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510(k) Data Aggregation
K Number
K173582Device Name
ThermiX Temperature Control Radiofrequency System, Accessories - RF Electrodes
Manufacturer
ThermiGen, L.L.C
Date Cleared
2018-01-17
(58 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
ThermiGen, L.L.C
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Thermi Temperature Controlled Radiofrequency (RF) System (generator, electrodes/hanpieces and accessories) are indicated:
- for use in dermatological and general surgical procedures for electrocoagulation and hemostasis
- to create lesions in nervous tissue
Device Description
The Thermi Temperature Controlled Radiofrequency (RF) System consists of a RF generator with integral temperature and impedance feedback, automatically adjusting energy delivery to maintain set temperature and percutaneous and transcutaneous electrodes accessories that deliver the RF to the targeted location on the patient's anatomy when use with Thermi RF generator. It is operating with set temperature range between 35-90° C that allows the physician to control treatment temperature to achieve the desired clinical outcome.
The Thermi RF System consist of:
- 1. RF Generator
- 2. Percutaneous electrodes
- 3. Disposable and re-usable transcutaneous electrodes/handpieces
- 4. Foot pedal
- 5. Power cord
Thermi RF generator produces an oscillating electric field in the antenna (electrode). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermocouple in the electrode measures this increase in temperature and maintains a feedback loop to ensure a set point temperature in the tissue.
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