Device Dossier

LOTUS Ultrasonic Surgical System & Accessories - Electrosurgical system, ultrasonic/mechanical vibration

Device Dossier for LOTUS Ultrasonic Surgical System & Accessories - Electrosurgical system, ultrasonic/mechanical vibration (Electrosurgical system,…

Intended purpose

Ultrasonic surgical equipment for cutting and coagulation of tissue. It is indicated for soft tissue surgical incisions when bleeding control and minimal thermal injury are important. It includes an energy-producing generator, a handpiece(s) with transducer tip(s) to convert and apply the energy, connecting cables, and a foot-switch as an option to regulate the energy. The System may be used as an adjunct to or substitute for electrosurgery, lasers, and traditional scalpels in general, plastic, gynaecologic, urologic, thoracic, exposure to orthopaedic structures (such as joint space),and other open and laparoscopic procedures in adult patients.

TGA Public Summary