FDA 510(k)

LYKOS辅助生殖激光器带动态靶向系统（DTS）

K号: K202241 · 2021-07-02

决定日期2021-07-02

产品代码MRX

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决定实质等同

器械摘要

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) is the device name listed in this FDA 510(k) record. The listed applicant is Hamilton Thorne, Inc.. It received FDA 510(k) clearance on 2021-07-02 under 510(k) number K202241. The device is classified under product code MRX. It was reviewed by the OB advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) is a medical device that received FDA 510(k) clearance on 2021-07-02. The listed applicant is Hamilton Thorne, Inc.. The 510(k) number is K202241.

When did LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) receive FDA 510(k) clearance?

LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) received FDA 510(k) clearance on 2021-07-02, under 510(k) number K202241.

Who is the listed applicant for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

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

What is the FDA product code for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS)?

The FDA product code for LYKOS Assisted Reproduction Laser with Dynamic Targeting System (DTS) is MRX.

列明Hamilton Thorne, 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。

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官方来源

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