Device Dossier

Sofwave, Sofwave System, Sofacia System, ArchMed System, ArchiMedUS System and ARC0 System - Ultrasonic skin contouring system

Device Dossier for Sofwave, Sofwave System, Sofacia System, ArchMed System, ArchiMedUS System and ARC0 System - Ultrasonic skin contouring system…

Intended purpose

Sofwave delivers high frequency ultrasonic pulses that elevate the temperature in the dermis layer and cause controlled isolated areas of thermal damage to achieve a desired aesthetic effect. The Sofwave is indicated for use as a non-invasive dermatological aesthetic treatment to improve facial lines and wrinkles for subjects aged 22 and older. The intended clinical performance of Sofwave is improvement of facial lines and wrinkles.

TGA Public Summary