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…
- GMDN category: 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.