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510(k) Data Aggregation
K Number
K130689Device Name
SYMPHONY RF GENERATOR
Manufacturer
THERMIGEN, INC.
Date Cleared
2013-11-15
(247 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
THERMIGEN, INC.
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The ThermiGen Symphony RF Generator System and the probes that are used with it are indicated
- . for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
- to create lesions in nervous tissue when used in combination with NeuroTherm . (previously Smith&Nephew) thermal/coagulation probes.
Device Description
The Symphony RF is a 20 watt electro-thermal radio frequency (RF) generator with integral temperature and impedance feedback. The RF generator is the Smith&Nephew RF Delivery Device, unchanged and in clinical service since Feb 25, 2004 (K033981). The Symphony RF has software changes to allow for two types of electrode/hand-pieces. (1) percutaneous (existing Smith and Nephew thermal/coagulation probes, now owned and manufactured by Neurotherm, Inc.) and (2) the new transcutaneous thermal/coagulation probe, RFE-10-D.
The Symphony RF generator has a user interface that displays temperature set point and actual tissue temperature, procedure time, impedance, along with system error and warning codes.
The theory of operation of RF devices: The RF generator produces an oscillating electric field in the antenna (handpiece). The oscillating electrical field is transmitted to the surrounding soft tissue, causing heating of the tissue. A thermistor intrinsic to the handpiece measures this increase in temperature and in the case of the Symphony RF, a feedback loop maintains a set point temperature in the tissue.
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