Sofwave, Sofwave System, Sofacia System, ArchMed System, ArchiMedUS System and ARC0 System - Ultrasonic skin contouring system
Access comprehensive regulatory information for Sofwave, Sofwave System, Sofacia System, ArchMed System, ArchiMedUS System and ARC0 System - Ultrasonic skin contouring system in the Australia medical device market through Pure Global AI's free TGA ARTG database. This Class IIa is sponsored by LC & Partners Pty Ltd, manufactured by Sofwave Medical Ltd in Israel. The device registration started on February 19, 2021.
This page provides complete registration details including sponsor information, manufacturer details, and regulatory compliance data from the official Australia TGA ARTG medical device database. Pure Global AI offers free access to Australia's complete medical device registry with 131,000+ devices, helping global MedTech companies navigate TGA regulations efficiently.
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.