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FDA Approves ThermiRF



Published December 23, 2013
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FDA Approves ThermiRF

ThermiAesthetics, creator of the ThermiRF temperature controlled radio frequency system, has received 510(k) clearance from the US Food and Drug Administration (FDA) for dermatological and general surgical applications in soft tissue and nerves. ThermiRF is the first aesthetic technology that applies the “science of heat” using temperature as a clinical endpoint enabling plastic surgeons and aesthetic physicians to precisely heat soft tissue and nerves to achieve desired aesthetic outcomes. ThermiRF is the first aesthetic device to deploy simultaneous dual monitoring of tissue temperature (internal and external) using advanced infrared imaging for precision treatments and unparalleled safety.

“This FDA Clearance establishes ThermiRF as a safe and effective device for the treatment of nerves and soft tissue, using thermistor-regulated delivery of energy for aesthetic applications,” said Paul Herchman, CEO of ThermiAesthetics. “Our unique technology has provided surgeons with access to an important and versatile platform, including both micro-surgical and non-invasive tools. We are excited to continue our penetration into the U.S. market and begin expansion of the ThermiRF solution to physicians worldwide.”

Since its pre-commercial introduction in the United States in 2012, general plastic and facial plastic surgeons, dermatologists and cosmetic surgeons from the United States and Canada have used ThermiRF in a variety of clinical areas. ThermiRF applications are targeted towards patients seeking an “in-between” solution for various aesthetic complaints. There is growing demand from baby boomers who are seeking advanced solutions which fall “in-between” non-invasive treatments and major surgery.
 
Brian M. Kinney, MD, a board-certified plastic surgeon, said, “Today’s aging baby boomers are asking for minimally invasive alternatives to traditional cosmetic surgery, but understand the limitations of topical, non-invasive approaches. ThermiRF allows me to provide safe and effective ‘in-between’ solutions for patients who are asking for longer lasting treatments for frown lines, wrinkles of the face or neck, or who desire to avoid or delay getting a facelift.  Now I have a tool which allows me to readily address these needs.”

More info: www.thermi.com


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