Thermi announced today that they have received a notice of completion to an 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 States. ThermiVa, a non-ablative radiofrequency application, has been cleared by the FDA for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. All Thermi products are marketed in accordance with their FDA-cleared indications, and Thermi supports a professional training program to ensure appropriate use of all ThermiRF devices.
A non-invasive, non-surgical, non-hormonal treatment, ThermiVa uses temperature-controlled radiofrequency energy to gently heat tissue. The in-office treatment which is cleared by the FDA, is available in more than 36 countries globally and has been used in more than 100,000 procedures worldwide.
ThermiVa is the most popular device for non-surgical vaginal rejuvenation on American Health & Beauty. Patients can research and contact nearly 500 providers who offer the procedure through AHB.
On July 30, 2018, the FDA released a statement to the public "FDA Warns Against Use of Energy-Based Devices to Perform Vaginal 'Rejuvenation' or Vaginal Cosmetic Procedures: FDA Safety Communication".
In September, Thermi released their new ARVATI platform featuring up to 50-watts of temperature-controlled monopolar radiofrequency energy using continuous wave technology - effectively heating skin 63% faster than before. The ARVATI will be the power unit behind newly purchased ThermiVa devices. Many practices have already upgraded to the new platform.
For more detailed information on the new platform, read AHB's ARVATI Review.