Temp-controlled radiofrequency tech developer Thermi said this week that the FDA granted it a notice of completion following an inquiry on products used in “vaginal rejuvenation” procedures.
Irving, Texas-based Thermi received a notice from the FDA on July 24 regarding specific claims about the company’s ThermiVa device. The ThermiVa is a non-ablative RF device cleared by the FDA for use in dermatological and general surgical procedures for electrocoagulation and hemostasis.
The ThermiVa is intended to be used in in-office treatments using temperature-controlled RF energy to gently heat tissue, Thermi said. The company added that it only markets its devices based on FDA-cleared indications.
“We are pleased to make this announcement and to have worked collaboratively and constructively with the FDA to address their inquiry. We will continue to maintain and further develop our relationship to ensure compliance to the agency’s directives and guidance for future clinical indications for use with all of the Thermi products,” global medical affairs VP Dr. Tara Margarella said in a prepared statement.
In July, FDA head Dr. Scott Gottlieb released a statement warning about “vaginal rejuvenation” procedures intended to treat conditions related to menopause, urinary incontinence or sexual function, saying that the products used in the procedures “don’t have adequate evidence to support their use for this purpose.”