VICTUS飞秒激光平台
K号: K200724 · 2020-09-01
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决定日期2020-09-01
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
VICTUS Femtosecond Laser Platform is the device name listed in this FDA 510(k) record. The listed applicant is Technolas Perfect Vision GmbH. It received FDA 510(k) clearance on 2020-09-01 under 510(k) number K200724. 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 VICTUS Femtosecond Laser Platform?
VICTUS Femtosecond Laser Platform is a medical device that received FDA 510(k) clearance on 2020-09-01. The listed applicant is Technolas Perfect Vision GmbH. The 510(k) number is K200724.
When did VICTUS Femtosecond Laser Platform receive FDA 510(k) clearance?
VICTUS Femtosecond Laser Platform received FDA 510(k) clearance on 2020-09-01, under 510(k) number K200724.
Who is the listed applicant for VICTUS Femtosecond Laser Platform?
The FDA 510(k) record lists Technolas Perfect Vision GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for VICTUS Femtosecond Laser Platform?
The FDA product code for VICTUS Femtosecond Laser Platform is OOE.
相关临床试验
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列明Technolas Perfect Vision GmbH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。
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。
K252682LenSx 激光系统（8065000944）Alcon Laboratories, Inc.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, LLC
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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