FDA 510(k)

Centurion®视觉系统（Active Sentry®）（8065753057）

K号: K233902 · 2024-01-10

决定日期2024-01-10

产品代码HQC

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决定实质等同

器械摘要

Centurion™ Vision System (Active Sentry™) (8065753057) is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2024-01-10 under 510(k) number K233902. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Centurion™ Vision System (Active Sentry™) (8065753057)?

Centurion™ Vision System (Active Sentry™) (8065753057) is a medical device that received FDA 510(k) clearance on 2024-01-10. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K233902.

When did Centurion™ Vision System (Active Sentry™) (8065753057) receive FDA 510(k) clearance?

Centurion™ Vision System (Active Sentry™) (8065753057) received FDA 510(k) clearance on 2024-01-10, under 510(k) number K233902.

Who is the listed applicant for Centurion™ Vision System (Active Sentry™) (8065753057)?

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

What is the FDA product code for Centurion™ Vision System (Active Sentry™) (8065753057)?

The FDA product code for Centurion™ Vision System (Active Sentry™) (8065753057) is HQC.

列明Alcon Laboratories, 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。

K254052DAILIES TOTAL1®; DAILIES TOTAL1® 多焦点 K252682LenSx 激光系统（8065000944）K243896LenSx 激光系统（8065998162）K243909Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal Toric K242184Alcon 27GA Chandelier（8065000252）；Alcon 27+ DS广角内窥镜照明器（8065000253）；Alcon 27+ DS内窥镜照明器（8065000256）；K233876UNITY VCS（8065000296）；UNITY CS（8065000297）

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相关器械（代码：HQC）

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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