GentleBeam (GB1000)
K号: K250692 · 2025-12-03
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器械摘要
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.
常见问题
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.
相关临床试验
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相关器械（代码：JAD）
关联记录通过名称、产品代码或其他元数据自动匹配。匹配不意味着已验证临床、科学、企业或监管关系；请查阅链接的官方来源。
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官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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