GentleBeam (GB1000)

GentleBeam (GB1000) is an FDA 510(k)-cleared medical device (K250692) manufactured by Voxel Ray Solutions, LLC. This device is classified under the Radiology specialty. FDA Device Class II (Special Controls) — moderate risk, requires 510(k) clearance. FDA clearance granted on December 2, 2025. Regulation: 8.