ReBorn (1050nm)
K号: K233962 · 2024-04-16
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决定日期2024-04-16
产品代码PKT
咨询委员会SU
请注意，您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同
器械摘要
ReBorn (1050nm) is the device name listed in this FDA 510(k) record. The listed applicant is Lightfective , Ltd.. It received FDA 510(k) clearance on 2024-04-16 under 510(k) number K233962. The device is classified under product code PKT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the ReBorn (1050nm)?
ReBorn (1050nm) is a medical device that received FDA 510(k) clearance on 2024-04-16. The listed applicant is Lightfective , Ltd.. The 510(k) number is K233962.
When did ReBorn (1050nm) receive FDA 510(k) clearance?
ReBorn (1050nm) received FDA 510(k) clearance on 2024-04-16, under 510(k) number K233962.
Who is the listed applicant for ReBorn (1050nm)?
The FDA 510(k) record lists Lightfective , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for ReBorn (1050nm)?
The FDA product code for ReBorn (1050nm) is PKT.
相关临床试验
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相关器械（代码：PKT）
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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