fe13b012-b2d0-4928-9d8a-057af98077c3UpdatePublished22023-06-192018-08-06In Commercial Distribution08809447652191PrimaryGS1N/AMetal Goggle (for patient)688282516Lutronic Corporation1Metal Goggle (for patient) of Advantage/Eco2/ACTIONII/SPECTRA/CLARITY/ LASEMD/ DENTAII / PICOPLUSfalsefalsefalsefalsefalsefalsefalsefalsefalsefalsefalsefalsefalseLabeling does not contain MRI Safety Informationtruetrue215-205-2219jvojir@lutronic.com58786Dermatological diode laser systemA mains electricity (AC-powered) device assembly in which input energy is used to excite a diode to emit a high-power therapeutic laser beam designed to perform dermatological procedures such as body hair removal (e.g., armpit, leg/arm, back, chest, bikini line, and face) and/or skin resurfacing (e.g., treatment of benign lesions, wrinkle reduction). It is intended to be used by a trained professional to emit pulsed light of a specific wavelength (e.g., around 808 nm or 1060 nm), delivered by a dedicated handpiece. It typically includes a control unit with dedicated software and user interface, delivery handpiece, and footswitch.falseActive36170General/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.falseActive36150General/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 TemperatureHandling Environment HumidityStorage Environment TemperatureStorage Environment Humidityfalsefalse