FDA 510(k)

GentleBeam (GB1000)

Número K: K250692 · 2025-12-03

Data da decisão2025-12-03

Código do produtoJAD

Comité consultivoRA

DecisãoSubstantially Equivalent

Resumo do dispositivo

GentleBeam (GB1000) is the device name listed in this FDA 510(k) record. The listed applicant is Voxel Ray Solutions, LLC. It received FDA 510(k) clearance on 2025-12-03 under 510(k) number K250692. The device is classified under product code JAD. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Perguntas frequentes

What is the GentleBeam (GB1000)?

GentleBeam (GB1000) is a medical device that received FDA 510(k) clearance on 2025-12-03. The listed applicant is Voxel Ray Solutions, LLC. The 510(k) number is K250692.

When did GentleBeam (GB1000) receive FDA 510(k) clearance?

GentleBeam (GB1000) received FDA 510(k) clearance on 2025-12-03, under 510(k) number K250692.

Who is the listed applicant for GentleBeam (GB1000)?

The FDA 510(k) record lists Voxel Ray Solutions, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GentleBeam (GB1000)?

The FDA product code for GentleBeam (GB1000) is JAD.

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