OptiLux LED 照明器
K号: K163185 · 2016-11-21
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器械摘要
OptiLux LED Illuminator is the device name listed in this FDA 510(k) record. The listed applicant is Isolux, LLC. It received FDA 510(k) clearance on 2016-11-21 under 510(k) number K163185. The device is classified under product code HBI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the OptiLux LED Illuminator?
OptiLux LED Illuminator is a medical device that received FDA 510(k) clearance on 2016-11-21. The listed applicant is Isolux, LLC. The 510(k) number is K163185.
When did OptiLux LED Illuminator receive FDA 510(k) clearance?
OptiLux LED Illuminator received FDA 510(k) clearance on 2016-11-21, under 510(k) number K163185.
Who is the listed applicant for OptiLux LED Illuminator?
The FDA 510(k) record lists Isolux, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for OptiLux LED Illuminator?
The FDA product code for OptiLux LED Illuminator is HBI.
相关临床试验
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相关器械（代码：HBI）
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
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