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FDA 510(k)

IVYLASER 手持脱毛机

K号: K230025 · 2023-07-03

决定日期2023-07-03
产品代码OHT
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决定实质等同

器械摘要

IVYLASER Handhold Hair Removal Machine is the device name listed in this FDA 510(k) record. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. It received FDA 510(k) clearance on 2023-07-03 under 510(k) number K230025. 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 IVYLASER Handhold Hair Removal Machine?

IVYLASER Handhold Hair Removal Machine is a medical device that received FDA 510(k) clearance on 2023-07-03. The listed applicant is Ivylaser (Beijing) Technology Co.,Ltd. The 510(k) number is K230025.

When did IVYLASER Handhold Hair Removal Machine receive FDA 510(k) clearance?

IVYLASER Handhold Hair Removal Machine received FDA 510(k) clearance on 2023-07-03, under 510(k) number K230025.

Who is the listed applicant for IVYLASER Handhold Hair Removal Machine?

The FDA 510(k) record lists Ivylaser (Beijing) Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IVYLASER Handhold Hair Removal Machine?

The FDA product code for IVYLASER Handhold Hair Removal Machine is OHT.

相关临床试验

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列明Ivylaser (Beijing) Technology Co.,Ltd为申报人的其他记录

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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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