Australia TGA ARTG recordSofwave, Sofwave System, Sofacia System, ArchMed System, ArchiMedUS System and ARC0 System - Ultrasonic skin contouring system
Australia TGA ARTG Registered Device · LC & Partners Pty Ltd · Sofwave Medical Ltd · Class IIa · Started February 19, 2021
Good Name: LC & Partners Pty Ltd - Sofwave, Sofwave System, Sofacia System, ArchMed System, ArchiMedUS System and ARC0 System - Ultrasonic skin contouring system
- Risk Class
- Class IIa
- Product Type
- Medical device system
- ARTG Category
- General
- Start Date
- February 19, 2021
- Effective Date
- February 19, 2021
- Country
- Israel
- Address
- 1 Ha-Otsma St 4th floor, Yokneam, IlIit, 2069200
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.
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.