SnapshotGLO (KB100)

The SnapshotGLO is a handheld wound imaging device that captures white light and fluorescence images of skin wounds at the point of care. It measures wound dimensions and uses autofluorescence imaging (395 nm excitation light) to visualize bacterial bioburden, helping clinicians identify wounds with bacterial loads >10⁴ CFU/gram when used alongside clinical signs and symptoms. The device does not diagnose or treat wounds.

SnapshotGLO uses a single RGB camera with 395 nm LED excitation (vs. predicate's 405 nm), captures autofluorescence and white light images, has an 11–13 cm working distance, features a 7-inch LCD display, and runs a customized Android-based OS. The predicate uses a 3-camera system with 405 nm excitation, 5.5-inch AMOLED display, and Android 9.1. Both measure wound dimensions stickerless, comply with IEC 60601 standards, use 940 nm laser distance finding, and operate from battery or wall power.

IEC 60601-1 (general electrical safety), IEC 60601-1-2 (EMC), IEC 60601-2-57 (imaging devices), IEC 60601-2-22 (lasers), and IEC 62471 (photobiological safety).

SnapshotGLO shares identical regulatory classification (Class II, QJF/FXN codes), intended use, and indications for use with the predicate MolecuLightDX. Nonclinical bench testing demonstrated SnapshotGLO detects bacterial fluorescence equivalently to the predicate in mono-, bi-microbial, and biofilm settings. Wound measurement testing showed comparable accuracy and repeatability. Clinical data from 40 patients showed SnapshotGLO achieved 75–82.5% accuracy versus the predicate's 52.5–65% when validated against culture results. The minor design differences (395 nm vs. 405 nm excitation, single vs. three cameras, different display) do not raise new safety or effectiveness questions and do not affect clinical performance.