Shani Darden LED光疗面罩
K号: K214103 · 2022-03-22
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决定日期2022-03-22
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
Shani Darden LED light therapy mask is the device name listed in this FDA 510(k) record. The listed applicant is Harpar Grace International. It received FDA 510(k) clearance on 2022-03-22 under 510(k) number K214103. 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 Shani Darden LED light therapy mask?
Shani Darden LED light therapy mask is a medical device that received FDA 510(k) clearance on 2022-03-22. The listed applicant is Harpar Grace International. The 510(k) number is K214103.
When did Shani Darden LED light therapy mask receive FDA 510(k) clearance?
Shani Darden LED light therapy mask received FDA 510(k) clearance on 2022-03-22, under 510(k) number K214103.
Who is the listed applicant for Shani Darden LED light therapy mask?
The FDA 510(k) record lists Harpar Grace International as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Shani Darden LED light therapy mask?
The FDA product code for Shani Darden LED light therapy mask 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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