Device Dossier

ACTITON - Electrosurgical system, ultrasonic/mechanical vibration

Device Dossier for ACTITON - Electrosurgical system, ultrasonic/mechanical vibration (Electrosurgical system, ultrasonic/mechanical vibration, Class IIb,…

Intended purpose

Ultrasonic cavitation surgical units is an assembly of devices that converts the high-frequency current into ultrasonic oscillation to mechanically fragment soft-tissue cells upon contact with a vibrating tip for cutting and/or coagulating tissue during surgery, possibly in combination with irrigation and aspiration. Ongoing vibration may create heat in cells (diathermy) to increase the cutting/coagulating capacity. It includes an energy-producing generator with monitoring functions, a handpiece(s) with tip(s) to convert and apply the energy, connecting cables, a foot-switch as an option to regulate the energy, and an irrigation/suction system.

TGA Public Summary