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FLUOBEAM LX and FLUOBEAM LM are intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. Upon intravenous administration and use of an ICG consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are indicated for use in capturing and viewing fluorescent images for the visualization of vessels, blood flow and tissue perfusion before, during and after organ transplant, plastic, micro- and reconstructive surgeries. The FLUOBEAM LX and FLUOBEAM LM can also be used to assist in the imaging of parathyroid glands and can be used as an adjunctive method to assist in the location of parathyroid glands due to the auto-fluorescence of this tissue. Use of the FLUOBEAM LX and FLUOBEAM LM devices are intended to assist, not replace, experienced visual assessment, and biopsy with conventional histopathological confirmation per standard of care. The system is not to be used to confirm the absence of parathyroid tissue or glands and is only to be used to assist in locating visually identified gland/tissues. Upon interstitial administration and use of ICG consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are used to perform intraoperative fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes. Upon administration and use of pafolacianine consistent with its approved labeling, the FLUOBEAM LX and FLUOBEAM LM are used to perform intraoperative fluorescence imaging of tissues that have taken up the drug.

FLUOBEAM LX and FLUOBEAM LM are imaging systems intended to provide real-time near infrared (NIR) fluorescence imaging of tissue during surgical procedures. Class 1 infrared laser light is used to excite the fluorescent tissues of parathyroid glands or the ICG or the pafolacianine and illuminate the regions of a patient's body to be observed. A camera inside the optical head captures the fluorescent image that is used to visualize the parathyroid glands or assess the blood vessels and related tissue perfusion. FLUOBEAM LX and FLUOBEAM LM consist of the following components: a hardware part with a camera unit (optical head) linked by a specific cable to a control box and a software part with FLUOSOFT LX or FLUOSOFT LM imaging software. The optical head contains a video camera and light sources (laser and LEDs) and is used by hand. The control box receives the video signal of the fluorescent image from the optical head, it digitizes it and sends it to a computer that outputs it on a display screen and/or records it. Adjustments of the fluorescent image are possible either by the optical head or via the FLUOSOFT LX imaging software and the FLUOSOFT LM imaging software on the computer. The subject devices FLUOBEAM LX and FLUOBEAM LM have therefore exactly the same principle of operation of the predicate device. Only aesthetic aspects are different between FLUOBEAM LX and FLUOBEAM LM. This Traditional 510(k) premarket notification of the FLUOBEAM LX and FLUOBEAM LM is to expand the indication for use statement to include the usage in the lymphatic system with the use of an ICG consistent with its approved label. This Traditional 510(k) premarket notification of the FLUOBEAM LX and FLUOBEAM LM is to expand the indication for use statement to include the additional cleared infrared dye, pafolacianine, for use with infrared imaging.