Device Dossier

Skin contouring system applicator, radio-frequency, monopolar

Device Dossier for Skin contouring system applicator, radio-frequency, monopolar (Skin contouring system applicator, radio-frequency, monopolar, Class…

Intended purpose

The device is a hands-free applicator intended for use in combination with the main device and with single use electrodes. The device is intended to provide local muscle stimulation and local tissue heating for the purpose of elevating tissue temperature and increase in local blood circulation resulting in strengthening of facial muscles and reduction of facial wrinkles and rhytids. The applicator with single use cheek electrode is intended to relieve symptoms associated with muscle spasm, treat temporomandibular joint (TMJ) dysfunction and pain, support muscle re-education, increase blood flow, and maintain or increase mandibular range of motion.

TGA Public Summary