Device Dossier

Radio-frequency skin surface treatment system applicator

Device Dossier for Radio-frequency skin surface treatment system applicator (Radio-frequency skin surface treatment system applicator, Class IIb, sponsor…

Intended purpose

A handpiece component of a radio-frequency skin surface treatment system designed to be used by the system operator to deliver bipolar radio-frequency (RF) energy to the skin surface for skin resurfacing. It is typically designed to deliver RF energy to the skin in a non-homogenous fractional manner, via an array of multi-electrode pins, to leave minimal-impact areas of skin to facilitate healing. The applicator connects with the system’s control unit. This is a reusable device.

TGA Public Summary