FDA 510(k)

UNITY VCS（8065000296）；UNITY CS（8065000297）

K号: K233876 · 2024-06-21

决定日期2024-06-21

产品代码HQC

咨询委员会OP 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

UNITY VCS (8065000296); UNITY CS (8065000297) 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 2024-06-21 under 510(k) number K233876. 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 UNITY VCS (8065000296); UNITY CS (8065000297)?

UNITY VCS (8065000296); UNITY CS (8065000297) is a medical device that received FDA 510(k) clearance on 2024-06-21. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K233876.

When did UNITY VCS (8065000296); UNITY CS (8065000297) receive FDA 510(k) clearance?

UNITY VCS (8065000296); UNITY CS (8065000297) received FDA 510(k) clearance on 2024-06-21, under 510(k) number K233876.

Who is the listed applicant for UNITY VCS (8065000296); UNITY CS (8065000297)?

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 UNITY VCS (8065000296); UNITY CS (8065000297)?

The FDA product code for UNITY VCS (8065000296); UNITY CS (8065000297) 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）；K233902Centurion®视觉系统（Active Sentry®）（8065753057）

查看所有 37 个设备 →

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。

K261264Stellaris Elite™视觉增强系统；后部和联合手术包：23号后部Elite™包(SE5423)；23号双刀片™玻璃体切割器后部Stellaris Elite™包(SE5423B)；25号后部Elite™包(SE5425)；25号双刀片™玻璃体切割器后部Stellaris Elite™包(SE5425B)；27号双刀片™玻璃体切割器后部Stellaris Elite™包(SE5427B)；23号双刀片™+玻璃体切割器后部Stellaris Elite™包(SE5423BB+)Bausch and Lomb K252052Stellaris Elite™视觉增强系统(BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, Incorporated K250501System SophiThis AG K243395MICOR 700 自动 I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 系统 (N/A)；MICOR 700 驱动器 (FG-50631)；MICOR 700 提取器 (FG-50621)；MICOR 700 视网膜剪刀 (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite视觉增强系统(BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

官方来源

在 FDA 数据库中查看 →

数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。