faceLITE
K号: K191629 · 2019-09-12
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决定日期2019-09-12
产品代码OHS
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
faceLITE is the device name listed in this FDA 510(k) record. The listed applicant is Ismart Marketing Svcs, Ltd.. It received FDA 510(k) clearance on 2019-09-12 under 510(k) number K191629. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the faceLITE?
faceLITE is a medical device that received FDA 510(k) clearance on 2019-09-12. The listed applicant is Ismart Marketing Svcs, Ltd.. The 510(k) number is K191629.
When did faceLITE receive FDA 510(k) clearance?
faceLITE received FDA 510(k) clearance on 2019-09-12, under 510(k) number K191629.
Who is the listed applicant for faceLITE?
The FDA 510(k) record lists Ismart Marketing Svcs, Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for faceLITE?
The FDA product code for faceLITE is OHS.
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相关器械（代码：OHS）
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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