LYNX 光凝器
K号: K242397 · 2024-10-25
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申请人Norlase Aps
决定日期2024-10-25
产品代码HQF
咨询委员会OP
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决定实质等同
器械摘要
LYNX Photocoagulator is the device name listed in this FDA 510(k) record. The listed applicant is Norlase Aps. It received FDA 510(k) clearance on 2024-10-25 under 510(k) number K242397. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LYNX Photocoagulator?
LYNX Photocoagulator is a medical device that received FDA 510(k) clearance on 2024-10-25. The listed applicant is Norlase Aps. The 510(k) number is K242397.
When did LYNX Photocoagulator receive FDA 510(k) clearance?
LYNX Photocoagulator received FDA 510(k) clearance on 2024-10-25, under 510(k) number K242397.
Who is the listed applicant for LYNX Photocoagulator?
The FDA 510(k) record lists Norlase Aps as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LYNX Photocoagulator?
The FDA product code for LYNX Photocoagulator is HQF.
相关临床试验
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列明Norlase Aps为申报人的其他记录
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：HQF）
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。
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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