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BLUE 400 and BLUE 400 S are accessories to the surgical microscope and allow the fluorescence observation of fluorophores with an excitation peak between 400 nm and the fluorescence emission observation comprising the spectrum in a spectral band of 620 - 710 nm. The ZEISS BLUE 400 and BLUE 400 S are surgical microscope accessories used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.

The BLUE 400 and BLUE 400 S are fluorescence accessories to qualified surgical microscopes, intended to allow intraoperative viewing of malignant glioma tissue grade III and IV under fluorescence. The overall system is comprised of excitation (illumination) and emission (observation) filters to detect fluorescence and are optimized in conjunction with the drug to pass light between 620 – 710 nanometers. The BLUE 400 S filters allow the surgical microscope to produce excitation light in a wavelength range covering at least 400 - 410 nanometers that excites an approved optical imaging agent and enables the surgeon to observe the emitted fluorescent signal in the oculars or on a display. Fluorescence of marked brain tissue helps visualization of tissue associated with Grade III & IV glioma during neurosurgeries. Compared to the blue visualization of the surrounding non-fluorescent tissue in the BLUE 400 image, BLUE 400 S is designed to visualize the surrounding nonfluorescent tissue more similar to white light impression, while tumor visualization of grade III and IV glioma remains consistent. With the visualization of non-fluorescent anatomy in an almost white light impression, BLUE 400 S is expected to allow PplX visualization with less frequent switching between fluorescence and white light imaging modes. BLUE 400 and BLUE 400 S can be installed only into qualified ZEISS surgical microscopes. For these accessories to be used with a qualified ZEISS surgical microscope, the critical components of the surgical microscope need to fulfill the clinically relevant parameters for the Indications for Use of BLUE 400 and BLUE 400 S.

The Myriad SPECTRA Light Source is an accessory to the Myriad System and delivers white light as well as excitation light for blue spectral range of 399 - 411 nm for use with an appropriate surgical microscope and fluorophore. The Myriad SPECTRA Light Source is used to provide supplemental excitation light for fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.

The Myriad SPECTRA Light Source used with the NICO Illumination Fiber and the NICO Delivery Sleeve delivers white light and 405 nm light to the surgical field when used with an appropriate surgical microscope and fluorophore. Surgical microscopes with the following characteristics are compatible with the Myriad SPECTRA Light Source: - Includes an accessory used in fluorescent visualization of suspected grade III and IV ● gliomas during neurosurgery. - The accessory enables viewing fluorescence of fluorophores with an excitation range ● between 380 nm - 430 nm and an observation band greater than 444 nm.

BLUE 400 is an accessory of the surgical microscope and allows the fluorescence observation of fluorophores with an excitation peak between 400 mm and the fluorescence emission observation comprising the spectrum in a spectral band of 620 - 710 nm. The ZEISS BLUE 400 is a surgical microscope accessory used in fluorescent visualization of suspected grade III and IV gliomas during neurosurgery.

The BLUE 400 is an accessory to the Zeiss surgical microscopes (OPMI PENTERO 800, OPMI PENTERO 900, and KINEVO 900), intended to allow intraoperative viewing of malignant glioma tissue under fluorescence. The BLUE 400 accessory is entirely composed of optical filters: the "Excitation" filter and the "Emission" filters. The Excitation filter is designed to filter all light wavelengths except 400 - 470 nanometers and is optimized to pass light between 400 - 410 nanometers. The Emission filters are designed to filter all light wavelengths except 430 - 800 nanometers and is optimized to pass light between 620 - 710 nanometers. When installed in the surgical microscopes (class I), the BLUE 400 introduces optical filters to the illumination and viewing optical paths. The BLUE 400 includes installation of a software license that facilitates use of the accessory. After the SW license is installed, the user has the option to switch from the normal white light mode of the surgical microscope to the BLUE 400 mode. The BLUE 400 accessory, when installed in the surgical microscopes, is intended to be used in conjunction with an approved optical imaging agent that is excited mainly in the wavelength range of 400 – 410 nanometers and fluoresces in the wavelength range of 620 - 710 nanometers.

The Leica FL400 is a surgical microscope accessory filter set for viewing fluorescence of fluorophores comprising an excitation filter for blue spectral range 380 mm - 430 nm and an observation filter comprising the long-wave blue, green, yellow and red spectrum in the spectral band greater than 444 nm. The FL400 is a surgical microscope accessory used in fluorescent visualization of suspected grade III or IV gliomas during neurosurgery.

The Leica FL400 is a fluorescence accessory that consists of an excitation (illumination) filter module and an emission (observation) filter module that are intended to be inserted into the optical beam path of compatible Leica surgical operating microscopes models M525 and M530. The excitation filter (380 nm - 430 nm), when placed into the light path, provides a fluorescence excitation light system for use in conjunction with an approved fluorophore selective for grade III or IV malignant gliomas. The emission filter is a long pass filter allowing light wavelengths greater than 444 nm to pass. The fluorophore emits light at a longer wavelength than the excitation light. Once passed through the emission filter module, a camera adapted to the surgical microscope detects the fluorescence signal, allowing the user to visualize the fluorophore in the open neurosurgery field. The Leica FL400 is supplied with a test phantom to confirm proper pre-operative fluorescence set-up. The Leica FL400 Test Phantom offers multiple levels of fluorescence intensity, which provides the clinician with a visual assessment of the FL400 pre-operative set-up. The clinician is advised to confirm the fluorescence spots are visible to confirm functionality prior to utilization.