LenSx 激光系统（8065000944）
K号: K252682 · 2025-09-24
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决定日期2025-09-24
产品代码OOE
咨询委员会OP
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决定实质等同
器械摘要
LenSx Laser System (8065000944) 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 2025-09-24 under 510(k) number K252682. The device is classified under product code OOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the LenSx Laser System (8065000944)?
LenSx Laser System (8065000944) is a medical device that received FDA 510(k) clearance on 2025-09-24. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K252682.
When did LenSx Laser System (8065000944) receive FDA 510(k) clearance?
LenSx Laser System (8065000944) received FDA 510(k) clearance on 2025-09-24, under 510(k) number K252682.
Who is the listed applicant for LenSx Laser System (8065000944)?
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 LenSx Laser System (8065000944)?
The FDA product code for LenSx Laser System (8065000944) is OOE.
相关临床试验
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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）K233902Centurion®视觉系统（Active Sentry®）（8065753057）
相关器械（代码：OOE）
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。
K243896LenSx 激光系统（8065998162）Alcon Laboratories, Inc.K223566ELITA™ 激光系统，ELITA™ 患者界面Johnson & Johnson Surgical Vision, Inc.K223838Catalys™ Precision激光系统Amo Manufacturing USA, LLCK220259ALLY自适应白内障治疗系统Lensar, Inc.K220516CATALYS 精密激光系统Amo Manufacturing USA, LLCK213559FEMTO LDV Z8飞秒激光手术仪Sie Ag,Surgical Instrument Engineering
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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