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

A mains (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-powered 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 devices) and controls/foot switch and emits a mid-infrared wavelength. It does not include frequency doubling technology.

TGA Public Summary