Device Dossier

Thermi Radio-frequency System - Radio-frequency lesion system

Device Dossier for Thermi Radio-frequency System - Radio-frequency lesion system (Radio-frequency lesion system, Class IIb, sponsor I-Medix). ARTG…

Intended purpose

The Thermi device is a radio frequency generator. The RF energy is delivered precisely via controlled electrodes for the purpose of soft tissue tightening by thermal coagulation / ablation and denervation by lesion creation. The electrodes that are connected to the generator have a temperature sensor at the tip that monitors soft tissue temperature and regulates energy delivery by the generator. The radio-frequency system and its accessories are not intended for gynaecological procedures including but not limited to the treatment of sexual dysfunction and/or urinary incontinence and vulvovaginal laxity.

TGA Public Summary