2305726e-2730-40a4-8015-e48d31d3644aNewPublished12025-02-262025-02-18In Commercial Distribution08800035501952PrimaryGS1HELIOS 785 Pico DIA FX 785 HandpieceHELIOS 785 Pico (1754V2) DIA FX 785 Handpiece689856875Laseroptek Co.,Ltd1HELIOS 785 Pico (1754V2) DIA FX 785 HandpiecefalsefalsefalsefalsefalsefalsefalsetruetruefalsefalsefalsefalseLabeling does not contain MRI Safety InformationtruefalseK24378000036150General/multiple surgical frequency-doubled 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, in which the frequency is doubled, intended to precisely cut, excise/vaporize, and coagulate tissues for general surgery, and/or multiple specialized surgical applications (non-dedicated). It includes a light source, delivery/positioning device(s), and controls/foot-switch and may be operated in continuous-wave or pulsed modes.falseActiveGEXPowered Laser Surgical InstrumentHandling Environment HumidityHandling Environment TemperatureStorage Environment HumidityStorage Environment Temperaturefalsefalse