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FDA 510(k)

痤疮光疗棒

K号: K160691 · 2016-06-21

申请人Zuko, Inc.
决定日期2016-06-21
产品代码OLP
咨询委员会SU 请注意,您提供的文本“SU”不足以进行翻译。请提供完整的描述性文本以便进行翻译。
决定实质等同

器械摘要

Acne Light Therapy Wand is the device name listed in this FDA 510(k) record. The listed applicant is Zuko, Inc.. It received FDA 510(k) clearance on 2016-06-21 under 510(k) number K160691. 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 Acne Light Therapy Wand?

Acne Light Therapy Wand is a medical device that received FDA 510(k) clearance on 2016-06-21. The listed applicant is Zuko, Inc.. The 510(k) number is K160691.

When did Acne Light Therapy Wand receive FDA 510(k) clearance?

Acne Light Therapy Wand received FDA 510(k) clearance on 2016-06-21, under 510(k) number K160691.

Who is the listed applicant for Acne Light Therapy Wand?

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

What is the FDA product code for Acne Light Therapy Wand?

The FDA product code for Acne Light Therapy Wand 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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