b7c1a019-532f-4566-9ae0-6aaadbcd94d4UpdatePublished22018-12-202018-09-282018-12-19Not in Commercial Distribution08033945938901PrimaryGS1Empower H65EMP-H65436045833QUANTA SYSTEM SPA1Distributed by Gyrus ACMI, L.P. falsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK18042300036170General/multiple surgical solid-state laser systemA mains electricity (AC-powered) device assembly in which input energy (e.g., flashlamp, diode laser) is used to excite a glass/crystal rod 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 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.falseActiveGEXPowered Laser Surgical Instrumentfalsefalse