Device Dossier

Visualase Cooled Laser Applicator System (VCLAS) - General/multiple surgical laser system beam guide, single-use

Device Dossier for Visualase Cooled Laser Applicator System (VCLAS) - General/multiple surgical laser system beam guide, single-use (General/multiple…

Intended purpose

The Visualase MRI Guided Laser Ablation System is indicated for use as a minimally invasive procedure to ablate necrotize or coagulate soft tissue through interstitial irradiation or thermal therapy under MRI guidance for wavelengths 800nm through 1064nm in cranial neurosurgery.

Functional description

The Visualase Cooled Laser Applicator System consists of a Laser Diffusing Fibre (LDF), a Cooling Catheter System, a Pump Tubing set and Tubing Extension Set for use with the Visualase System circulation pump, and a drainage bag for coolant collection. The LDF receives laser light from a medical grade laser and evenly distributes it circumferentially at the distal tip. This device is designed to handle wavelengths between 800nm and 1064nm.

TGA Public Summary