Device Dossier

General/multiple surgical laser system beam guide

Device Dossier for General/multiple surgical laser system beam guide (General/multiple surgical laser system beam guide, Class IIa, sponsor High Tech…

Intended purpose

A flexible, probe-like device intended to be connected to a general/multiple surgical laser system to invasively direct and deliver laser energy for multiple different surgical applications (non-dedicated), which may include vaporization, ablation, coagulation, haemostasis, excision, resection, incision of soft and cartilaginous tissue, and/or fragmentation of urinary and biliary calculi. It typically consists of fibreoptic materials with an invasive laser-firing distal end. This is a reusable device intended to be sterilized prior to use.

TGA Public Summary