FDA 510(k)

LED面部遮光仪

K号: K213056 · 2022-07-07

申请人Shenzhen Osto Technology Company Limited

决定日期2022-07-07

产品代码OLP

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决定实质等同

器械摘要

LED Facial Mask is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Osto Technology Company Limited. It received FDA 510(k) clearance on 2022-07-07 under 510(k) number K213056. 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 LED Facial Mask?

LED Facial Mask is a medical device that received FDA 510(k) clearance on 2022-07-07. The listed applicant is Shenzhen Osto Technology Company Limited. The 510(k) number is K213056.

When did LED Facial Mask receive FDA 510(k) clearance?

LED Facial Mask received FDA 510(k) clearance on 2022-07-07, under 510(k) number K213056.

Who is the listed applicant for LED Facial Mask?

The FDA 510(k) record lists Shenzhen Osto Technology Company Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Facial Mask?

The FDA product code for LED Facial Mask is OLP.

列明Shenzhen Osto Technology Company Limited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。

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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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