Device Dossier
Surgical Ho:YAG laser system
Device Dossier for Surgical Ho:YAG laser system (General/multiple surgical solid-state laser system, Class IIb, sponsor Innologic). ARTG record, intended…
- GMDN category: General/multiple surgical solid-state laser system
Intended purpose
A mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a doped glass/crystal medium to emit a high-power laser beam intended for general surgery and/or multiple specialized surgical applications (non-dedicated), which may include treatment of vascular diseases. It vaporizes/ablates/morcellates soft tissue with moderate haemostasis, little charring, and a thin zone of necrosis. It includes a light source, delivery/positioning device(s), and controls/foot-switch and emits a midinfrared wavelength. It does not include frequency doubling technology.