LUTRONIC GENIUS
K号: K253484 · 2026-06-29
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决定日期2026-06-29
产品代码GEI
咨询委员会SU
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决定实质等同
器械摘要
LUTRONIC GENIUS is the device name listed in this FDA 510(k) record. The listed applicant is Cynosure Lutronic Technology Corporation. It received FDA 510(k) clearance on 2026-06-29 under 510(k) number K253484. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LUTRONIC GENIUS?
LUTRONIC GENIUS is a medical device that received FDA 510(k) clearance on 2026-06-29. The listed applicant is Cynosure Lutronic Technology Corporation. The 510(k) number is K253484.
When did LUTRONIC GENIUS receive FDA 510(k) clearance?
LUTRONIC GENIUS received FDA 510(k) clearance on 2026-06-29, under 510(k) number K253484.
Who is the listed applicant for LUTRONIC GENIUS?
The FDA 510(k) record lists Cynosure Lutronic Technology Corporation as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LUTRONIC GENIUS?
The FDA product code for LUTRONIC GENIUS is GEI.
相关临床试验
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。
相关器械（代码：GEI）
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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