FDA 510(k)

RxSight 接触镜

K号: K201909 · 2020-09-10

决定日期2020-09-10

产品代码HJK

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决定实质等同

器械摘要

RxSight Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Rxsight, Inc.. It received FDA 510(k) clearance on 2020-09-10 under 510(k) number K201909. The device is classified under product code HJK. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the RxSight Contact Lens?

RxSight Contact Lens is a medical device that received FDA 510(k) clearance on 2020-09-10. The listed applicant is Rxsight, Inc.. The 510(k) number is K201909.

When did RxSight Contact Lens receive FDA 510(k) clearance?

RxSight Contact Lens received FDA 510(k) clearance on 2020-09-10, under 510(k) number K201909.

Who is the listed applicant for RxSight Contact Lens?

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

What is the FDA product code for RxSight Contact Lens?

The FDA product code for RxSight Contact Lens is HJK.

列明Rxsight, 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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