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FDA 510(k)

IPL脱毛设备,型号:AI01

K号: K212897 · 2021-11-04

决定日期2021-11-04
产品代码OHT
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

IPL Hair Removal Device, model: AI01 is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Century Dongyuan Technology CO , Ltd.. It received FDA 510(k) clearance on 2021-11-04 under 510(k) number K212897. The device is classified under product code OHT. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IPL Hair Removal Device, model: AI01?

IPL Hair Removal Device, model: AI01 is a medical device that received FDA 510(k) clearance on 2021-11-04. The listed applicant is Shenzhen Century Dongyuan Technology CO , Ltd.. The 510(k) number is K212897.

When did IPL Hair Removal Device, model: AI01 receive FDA 510(k) clearance?

IPL Hair Removal Device, model: AI01 received FDA 510(k) clearance on 2021-11-04, under 510(k) number K212897.

Who is the listed applicant for IPL Hair Removal Device, model: AI01?

The FDA 510(k) record lists Shenzhen Century Dongyuan Technology CO , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IPL Hair Removal Device, model: AI01?

The FDA product code for IPL Hair Removal Device, model: AI01 is OHT.

相关临床试验

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。

列明Shenzhen Century Dongyuan Technology CO , 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:OHT)

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。

官方来源

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