FLUOBEAM LX Imaging System (FBLX); FLUOBEAM LM Imaging System (FBLM)

FLUOBEAM LX and FLUOBEAM LM are near-infrared fluorescence imaging systems used during surgery to visualize tissue perfusion, blood vessels, parathyroid glands, and lymphatic structures. The devices use Class 1 infrared laser light to excite fluorescent contrast agents (ICG or pafolacianine) and capture real-time images to assist surgeons during organ transplant, plastic, reconstructive, and other surgical procedures.

The subject devices emit Class 1 laser light at 750nm wavelength to generate fluorescent light in the 800-900nm range, with an excitation intensity of 5.0±0.5 mW/cm² at 20cm and working distance of 8-45cm. They use a color CMOS sensor camera and include software (FLUOSOFT LX/LM) for image adjustment. Only aesthetic aspects differ between the FLUOBEAM LX and FLUOBEAM LM models.

Not stated in this summary.

The subject devices have identical principle of operation and technological characteristics to the predicate FLUOBEAM LX (K233564), which was previously cleared by FDA. Bench testing demonstrated the devices can image ICG at various concentrations for lymphatic visualization and pafolacianine at multiple concentrations. Comparative testing against the reference device (VS3-Iridium, K223020) showed FLUOBEAM can visualize ICG at similar concentrations and pafolacianine at lower concentrations with equivalent or superior image contrast (SNR), establishing comparable performance despite minor wavelength differences. The expansion of indications does not introduce new safety or effectiveness concerns, as user profiles, training, environment, and workflow remain unchanged.