Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 a medical device manufactured by Voxel Ray Solutions, LLC. It received FDA 510(k) clearance on 2025-12-03 under approval 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. It is manufactured by Voxel Ray Solutions, LLC. The 510(k) number is K250692.

When was GentleBeam (GB1000) approved by the FDA?

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

What company makes GentleBeam (GB1000)?

GentleBeam (GB1000) is manufactured by Voxel Ray Solutions, LLC.

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

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

Related Devices (Code: JAD)

K162568INTRABEAM 600Carl Zeiss Meditec, AG K153570Axxent Electronic Brachytherapy System Model 110 XP 1200Icad, Inc. K172080Photoelectric Therapy SystemXstrahl, Ltd. K173425SRT-100+Sensus Healthcare, Inc. K190255Sensus Healthcare TVM Balloon ApplicatorSensus Healthcare, Inc. K182641Sensus IORT SystemSensus 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.

↑