Device Dossier

General/multiple surgical solid-state laser system

Device Dossier for General/multiple surgical solid-state laser system (General/multiple surgical solid-state laser system, Class IIb, sponsor Elwyn Laser…

Intended purpose

This high-power high-density laser beam with a wavelength of 2100nm transmits laser energy to target tissue through the optical laser fiber transmission system for therapeutic purposes. The system, along with its accessories is designed for both urological lithotripsy, benign prostatic hyperplasia. Additionally, it is suitable for gynaecology, ENT and other diverse treatment applications.

TGA Public Summary