Device Dossier

Radio-frequency skin treatment and muscle conditioning system - Radio-frequency skin surface treatment/fat liquefaction system control unit

Device Dossier for Radio-frequency skin treatment and muscle conditioning system - Radio-frequency skin surface treatment/fat liquefaction system control…

Intended purpose

The system and its accessories are intended for dermatological procedures requiring ablation and resurfacing of the skin when using a microneedling RF applicator. It is also intended for use in dermatologic and general surgical procedures for non-invasive treatment when using radio frequency energy, and for muscle conditioning to stimulate healthy muscles when using a dedicated muscle stimulation applicator. The system is intended to be operated by a licensed healthcare practitioner who is present to monitor treatment.

TGA Public Summary