Silk'n MODEL H5003设备
K号: K180279 · 2018-05-09
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决定日期2018-05-09
产品代码NGX
咨询委员会PM
请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。
决定实质等同
器械摘要
Silk'n MODEL H5003 device 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 2018-05-09 under 510(k) number K180279. The device is classified under product code NGX. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Silk'n MODEL H5003 device?
Silk'n MODEL H5003 device is a medical device that received FDA 510(k) clearance on 2018-05-09. The listed applicant is Home Skinovations , Ltd.. The 510(k) number is K180279.
When did Silk'n MODEL H5003 device receive FDA 510(k) clearance?
Silk'n MODEL H5003 device received FDA 510(k) clearance on 2018-05-09, under 510(k) number K180279.
Who is the listed applicant for Silk'n MODEL H5003 device?
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 MODEL H5003 device?
The FDA product code for Silk'n MODEL H5003 device is NGX.
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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。
相关器械（代码：NGX）
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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