CLAREON MONARCH IV IOL 输送系统
K号: K212039 · 2021-08-23
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决定日期2021-08-23
产品代码MSS
咨询委员会OP
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决定实质等同
器械摘要
CLAREON MONARCH IV IOL Delivery System 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 2021-08-23 under 510(k) number K212039. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the CLAREON MONARCH IV IOL Delivery System?
CLAREON MONARCH IV IOL Delivery System is a medical device that received FDA 510(k) clearance on 2021-08-23. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K212039.
When did CLAREON MONARCH IV IOL Delivery System receive FDA 510(k) clearance?
CLAREON MONARCH IV IOL Delivery System received FDA 510(k) clearance on 2021-08-23, under 510(k) number K212039.
Who is the listed applicant for CLAREON MONARCH IV IOL Delivery System?
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 CLAREON MONARCH IV IOL Delivery System?
The FDA product code for CLAREON MONARCH IV IOL Delivery System is MSS.
相关临床试验
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。
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 ToricK242184Alcon 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）
相关器械（代码：MSS）
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。
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。
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