Device Dossier

Virtue RF - Radio-frequency skin surface treatment system

Device Dossier for Virtue RF - Radio-frequency skin surface treatment system (Radio-frequency skin surface treatment system, Class IIb, sponsor Anovia).…

Intended purpose

The Virtue RF System is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. Smart RF Handpiece: The Smart RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis, and the percutaneous treatment of facial wrinkles. The VirtueRF Electrosurgical System for facial wrinkles is intended for use with Skin Types 1-V. The Smart RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The with 2MHz functionality is not intended to treat wrinkles. Exact RF Handpiece: The Exact RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Exact RF Handpiece is not intended to treat wrinkles. Deep RF Handpiece: The Deep RF Handpiece with 1MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 1MHz functionality is not intended to treat wrinkles. The Deep RF Handpiece with 2MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 2MHz functionality is not intended to treat wrinkles. The Deep RF Handpiece with 0.5MHz functionality is intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis. The Deep RF handpiece with 0.5MHz functionality is not intended to treat wrinkles.

TGA Public Summary