FDA 510(k)

MolecuLight I:X

K号: K210882 · 2021-06-22

决定日期2021-06-22

产品代码QJF

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决定实质等同

器械摘要

MolecuLight I:X is the device name listed in this FDA 510(k) record. The listed applicant is MolecuLight, Inc.. It received FDA 510(k) clearance on 2021-06-22 under 510(k) number K210882. The device is classified under product code QJF. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the MolecuLight I:X?

MolecuLight I:X is a medical device that received FDA 510(k) clearance on 2021-06-22. The listed applicant is MolecuLight, Inc.. The 510(k) number is K210882.

When did MolecuLight I:X receive FDA 510(k) clearance?

MolecuLight I:X received FDA 510(k) clearance on 2021-06-22, under 510(k) number K210882.

Who is the listed applicant for MolecuLight I:X?

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

What is the FDA product code for MolecuLight I:X?

The FDA product code for MolecuLight I:X is QJF.

列明MolecuLight, Inc.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。

K213840MolecuLight I:X K211901MolecuLightDX K191371MolecuLight i:X

官方来源

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