Thermi Receives Notice Of Complete And Satisfactory Closure Of FDA’s “Vaginal Rejuvenation” InquiryIRVING, Texas, Nov. 15, 2018 /PRNewswire/ -- Thermi®, an Almirall, S.A. company, today announced that it has received a notice of completion to a U.S. Food and Drug Administration (FDA) inquiry on products used in "vaginal rejuvenation" procedures. Thermi received an "It has come to our attention" notice from the FDA on July 24, 2018 regarding specific claims about the company's ThermiVa® device in the United [...]
The ARVATI device is intended to create lesions in nervous tissue and for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
Thermi®‘s temperature controlled RF system is indicated:
• In the United States for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
• In Europe for electrocoagulation of soft tissues for vulvovaginal laxity.
Important Safety Considerations:
Thermi radiofrequency products should not be used on patients who are pregnant, have a fever or skin infection in or around the area of treatment. Expected procedure side effects may include transient pain in the procedure area, erythema and edema.