FDA 510(k)

NutraStim Hair Laser Helmet

K号: K160728 · 2016-09-16

决定日期2016-09-16

产品代码OAP

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决定实质等同

器械摘要

NutraStim Hair Laser Helmet is the device name listed in this FDA 510(k) record. The listed applicant is Nutra Luxe MD, LLC. It received FDA 510(k) clearance on 2016-09-16 under 510(k) number K160728. The device is classified under product code OAP. It was reviewed by the PM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the NutraStim Hair Laser Helmet?

NutraStim Hair Laser Helmet is a medical device that received FDA 510(k) clearance on 2016-09-16. The listed applicant is Nutra Luxe MD, LLC. The 510(k) number is K160728.

When did NutraStim Hair Laser Helmet receive FDA 510(k) clearance?

NutraStim Hair Laser Helmet received FDA 510(k) clearance on 2016-09-16, under 510(k) number K160728.

Who is the listed applicant for NutraStim Hair Laser Helmet?

The FDA 510(k) record lists Nutra Luxe MD, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NutraStim Hair Laser Helmet?

The FDA product code for NutraStim Hair Laser Helmet is OAP.

列明Nutra Luxe MD, LLC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：OAP）

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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