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FDA Clears Renuvion Dermal Headpiece for Wrinkle-Reduction Procedures 


Apyx Medical Corp., the manufacturer of Renuvion®, a proprietary helium plasma and radiofrequency technology, previously announced the receipt of U.S. 510(k) clearance for the use of the Renuvion Dermal handpiece for specific dermatological procedures for the treatment of moderate to severe wrinkles and rhytides, limited to patients with Fitzpatrick skin types I, II or III.

Branded as Facial Renewal, this treatment for wrinkle-reduction provides patients with a nonsurgical option for smoothing and contracting the skin in one procedure. Facial Renewal enables dermatologists, plastic surgeons, and cosmetic physicians to achieve transformative results, without the patient needing invasive surgery or risking looking unnatural, according to company officials.  

“Renuvion for facial procedures is groundbreaking. It’s a treatment that fulfills a big unmet need in cosmetic procedures,” says New York oculoplastic surgeon Tabasum Mir, MD. “I have been using the Renuvion technology on patients in my practice and I’ve seen the transformative results firsthand. With the new clearance for Facial Renewal, this opens a whole new treatment option for patients to achieve the youthful appearance they’re seeking.”

Charlie Goodwin, president and CEO of Apyx Medical, also spoke out about the clearance, commenting:  “We are very pleased to receive FDA clearance with a specific clinical indication that enables Apyx Medical to market and sell our Renuvion Technology to physicians and patients for use in dermal resurfacing procedures. Facial Renewal with Renuvion offers patients a refreshed and more youthful look without having the unnatural ‘pulled’ appearance often associated with a facelift.”



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