Omnilux CLEAR
K号: K210948 · 2021-06-24
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决定日期2021-06-24
产品代码OLP
咨询委员会SU
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决定实质等同
器械摘要
Omnilux CLEAR is the device name listed in this FDA 510(k) record. The listed applicant is Globalmed Technologies. It received FDA 510(k) clearance on 2021-06-24 under 510(k) number K210948. The device is classified under product code OLP. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Omnilux CLEAR?
Omnilux CLEAR is a medical device that received FDA 510(k) clearance on 2021-06-24. The listed applicant is Globalmed Technologies. The 510(k) number is K210948.
When did Omnilux CLEAR receive FDA 510(k) clearance?
Omnilux CLEAR received FDA 510(k) clearance on 2021-06-24, under 510(k) number K210948.
Who is the listed applicant for Omnilux CLEAR?
The FDA 510(k) record lists Globalmed Technologies as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Omnilux CLEAR?
The FDA product code for Omnilux CLEAR is OLP.
相关临床试验
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相关器械（代码：OLP）
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
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