FDA 510(k)

Silk'n HST

K号: K162784 · 2017-03-25

决定日期2017-03-25

产品代码OHS

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决定实质等同

器械摘要

Silk'n HST is the device name listed in this FDA 510(k) record. The listed applicant is Home Skinovations , Ltd.. It received FDA 510(k) clearance on 2017-03-25 under 510(k) number K162784. 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 Silk'n HST?

Silk'n HST is a medical device that received FDA 510(k) clearance on 2017-03-25. The listed applicant is Home Skinovations , Ltd.. The 510(k) number is K162784.

When did Silk'n HST receive FDA 510(k) clearance?

Silk'n HST received FDA 510(k) clearance on 2017-03-25, under 510(k) number K162784.

Who is the listed applicant for Silk'n HST?

The FDA 510(k) record lists Home Skinovations , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Silk'n HST?

The FDA product code for Silk'n HST is OHS.

列明Home Skinovations , Ltd.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：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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