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FDA 510(k)

GentleBeam (GB1000)

K-Number: K250692 · 2025-12-03

ApplicantVoxel Ray Solutions, LLC
Decision Date2025-12-03
Product CodeJAD
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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.

Related Devices (Code: JAD)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K241174INTRABEAM (700); And accessories (INTRABEAM SMART Stand, INTRABEAM SMART Spherical Applicator, INTRABEAM Spherical Sizer Set, INTRABEAM Needle Applicator)Carl Zeiss Meditec, AGK230611X80 / RADiant / PhotoElectric Therapy System (RADiant Aura)Xstrahl, Ltd.K213942EsteyaNucletron B.V.K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc.K182641Sensus IORT SystemSensus Healthcare, Inc.K173425SRT-100+Sensus Healthcare, Inc.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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