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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.

The GLOW800 is a Leica Surgical Microscope accessory used in viewing intra-operative blood flow and related tissue perfusion in the cerebral vascular region as well as blood flow following plastic and reconstructive surgery and coronary artery bypass grafting (CABG).

Similar to the predicate device (Leica FL800 most recently cleared under K141136 and previously in K061871 and K080612), the GLOW800 is an accessory to the Leica Microsystems (LMS) Class I 510(k) exempt surgical operating microscope (SOM). The GLOW800, a non-contact, non-invasive device similar to its predicate, allows the surgical microscope to produce excitation light and resolve fluorescent emission from the fluorescent agent Indocyanine green (ICG). The generated fluorescence signal depicts the distribution of the infra-red dye in the patient's blood vessels during the surgical procedure (fluorescence video angiography). The ICG fluorescence peak is captured for display on the SOM screen. Using an additional camera to capture the visible light (VL) video stream and digitally combining with the Near Infra-red (NIR) video stream presents a high definition display of the surgical site as a pseudocoloured combined image of the same field of view (FOV), which includes anatomical information. The GLOW800 utilizes the illumination light source, supplied as standard with the SOM to produce excitation light which is filtered using an illumination filter (also referred to as the excitation filter) within the 750 and 800 spectral wavelength range.

The Leica FL560 is a surgical microscope accessory used in viewing intra-operative blood flow in the cerebral vascular area.

Similar to the predicate device (Leica FL800 ULT approved under K141136), the Leica FL560 is an accessory to the Leica Microsystems (LMS) Class I 510(k) exempt surgical operating microscope (SOM). The Leica FL560 utilizes the illumination light source, supplied as standard with the SOM to produce excitation light which is filtered using an illumination filter (also referred to as the excitation filter) within the 460 - 500nm wavelength. An observation filter is introduced into the observer light path within the optics carrier of the SOM to enable visualization of the resulting fluorescence emission comprising of the green, yellow and red spectrum in a spectral band above ~510nm.

The Leica FL800 is a surgical microscope accessory used in viewing bypass grafts during coronary artery bypass (CABG) surgery, as well as blood flow during plastic and reconstructive surgery.

The Leica FL800 device is an accessory to the Leica surgical microscopes. It allows the surgical microscope to produce excitation light and resolve fluorescence light from the fluorescent agent ICG. The generated fluorescence signal depicts the distribution of the infrared doct in the patient's blood vessels during the operation (fluorescence video angiography).