Device Dossier

SCIZER - Hyperthermia system, ultrasound

Device Dossier for SCIZER - Hyperthermia system, ultrasound (Hyperthermia system, ultrasound, Class IIb, sponsor Classys). ARTG record, intended purpose,…

Intended purpose

A non-invasive therapeutic device for the treatment of lipomas and reduction of subcutaneous adipose tissue using the principle of coagulation and necrosis in the body. This device is a Focused Ultrasound Therapeutic System to provide a non-invasive approach by delivering focused ultrasound energy, which achieves disruption of mature adipose tissue located in the subcutaneous tissues.

TGA Public Summary