BOTHELL, Wash., Oct. 4, 2017 /PRNewswire/ -- Solta Medical, a division of Valeant Pharmaceuticals North America LLC, announced today that its Thermage FLX™ System received 510(k) clearance from the U.S. Food and Drug Administration (FDA) to non-invasively smooth skin on the face, eyes, and body.
Thermage FLX is the newest generation of Thermage® technologies known for non-invasively reducing the appearance of fine lines and wrinkles. The system uses patented radiofrequency technology to create a uniform heating effect in the deep collagen-rich layers of the skin. This gentle heating tightens existing collagen and stimulates the production of new collagen, all with little-to-no downtime for the patient. The Thermage FLX features a new optimized energy delivery algorithm, known as AccuREP™ technology, which automatically measures and precisely tunes the amount of energy delivered to the patient and treatment area. The system also features a new vibrating hand-piece to help enhance patient comfort, and a new, larger treatment tip that reduces treatment time by 25 percent.
"As pioneers in the aesthetic market, Solta Medical has continued to evolve the Thermage technology to improve upon the efficacy, comfort, and results physicians and their patients have come to expect from the brand," said James Hartman, vice president and general manager, Solta Medical. "The FDA 510(k) clearance of Thermage FLX marks a momentous occasion during the brand's 15 year anniversary and demonstrates our commitment to our customers as we continue to develop innovative ways to improve on our existing technologies."
According to the American Society for Aesthetic Plastic Surgery (ASAPS), the number of skin tightening procedures increased over 77% between 2014 and 2016. With the launch of the Thermage FLX system, Solta Medical is well positioned to help practices take advantage of this continuously growing trend. And while busy consumers continue to look for ways to maximize the use of their time, Thermage FLX treatments are now faster than ever, allowing patients to quickly return to their daily routine.
"Being among the first adopters of the technology, I have confidently used the system for over a decade, as it is the center-piece of a successful skin tightening program," said Michael S. Kaminer, M.D., founding partner of SkinCare Physicians. "The Thermage system, backed by more than 50 clinical studies, is the gold standard in our practice and our most popular skin smoothing treatment. I'm excited to see what the new Thermage FLX system has to offer as each subsequent version has proven to exceed my expectations."
The new Thermage FLX system is expected to be commercially available during the last quarter of 2017.
About Solta Medical
Solta Medical, a division of Valeant Pharmaceuticals North America LLC, is a global leader in the medical aesthetics market that helps drive revenue growth to aesthetic practices by providing innovative and effective skin rejuvenation and body contouring solutions. Solta offers seven aesthetic energy devices to address a range of skin-related concerns, including skin resurfacing and rejuvenation, body contouring, fat reduction, skin smoothing, hair removal, and acne reduction. More than five million procedures have been performed with Solta Medical's portfolio of products around the world. More information can be found at www.solta.com.
Valeant Pharmaceuticals International, Inc. (NYSE/TSX: VRX) is a multinational specialty pharmaceutical company that develops, manufactures and markets a broad range of pharmaceutical products primarily in the areas of dermatology, gastrointestinal disorders, eye health, neurology and branded generics. More information about Valeant can be found at www.valeant.com.
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SOURCE Solta Medical