医疗二极管激光系统
K号: K230047 · 2024-03-04
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决定日期2024-03-04
产品代码NVK
咨询委员会SU
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决定实质等同
器械摘要
Medical Diode Laser Systems is the device name listed in this FDA 510(k) record. The listed applicant is Gigaalaser Company , Ltd.. It received FDA 510(k) clearance on 2024-03-04 under 510(k) number K230047. The device is classified under product code NVK. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Medical Diode Laser Systems?
Medical Diode Laser Systems is a medical device that received FDA 510(k) clearance on 2024-03-04. The listed applicant is Gigaalaser Company , Ltd.. The 510(k) number is K230047.
When did Medical Diode Laser Systems receive FDA 510(k) clearance?
Medical Diode Laser Systems received FDA 510(k) clearance on 2024-03-04, under 510(k) number K230047.
Who is the listed applicant for Medical Diode Laser Systems?
The FDA 510(k) record lists Gigaalaser Company , Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Medical Diode Laser Systems?
The FDA product code for Medical Diode Laser Systems is NVK.
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。
列明Gigaalaser Company , Ltd.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：NVK）
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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