Device Dossier

General/multiple surgical laser system beam guide, single-use

Device Dossier for General/multiple surgical laser system beam guide, single-use (General/multiple surgical laser system beam guide, single-use, Class…

Intended purpose

A sterile, surgical 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 is typically a probe-, handpiece-, or tip-like device which includes fibreoptic materials. This is a single-use device.

TGA Public Summary