FDA 510(k)

LYMA激光

K号: K210823 · 2022-03-18

决定日期2022-03-18

产品代码OHS

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决定实质等同

器械摘要

LYMA Laser is the device name listed in this FDA 510(k) record. The listed applicant is Lyma Life , Ltd.. It received FDA 510(k) clearance on 2022-03-18 under 510(k) number K210823. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LYMA Laser?

LYMA Laser is a medical device that received FDA 510(k) clearance on 2022-03-18. The listed applicant is Lyma Life , Ltd.. The 510(k) number is K210823.

When did LYMA Laser receive FDA 510(k) clearance?

LYMA Laser received FDA 510(k) clearance on 2022-03-18, under 510(k) number K210823.

Who is the listed applicant for LYMA Laser?

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

What is the FDA product code for LYMA Laser?

The FDA product code for LYMA Laser is OHS.

列明Lyma Life , 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。

K243330LYMA 激光 PRO

相关器械（代码：OHS）

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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