Catalys Precision激光系统
K号: K182083 · 2018-11-09
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决定日期2018-11-09
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
Catalys Precision Laser System is the device name listed in this FDA 510(k) record. The listed applicant is Amo Manufacturing USA, LLC. It received FDA 510(k) clearance on 2018-11-09 under 510(k) number K182083. 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 Catalys Precision Laser System?
Catalys Precision Laser System is a medical device that received FDA 510(k) clearance on 2018-11-09. The listed applicant is Amo Manufacturing USA, LLC. The 510(k) number is K182083.
When did Catalys Precision Laser System receive FDA 510(k) clearance?
Catalys Precision Laser System received FDA 510(k) clearance on 2018-11-09, under 510(k) number K182083.
Who is the listed applicant for Catalys Precision Laser System?
The FDA 510(k) record lists Amo Manufacturing USA, LLC as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Catalys Precision Laser System?
The FDA product code for Catalys Precision Laser System is OOE.
相关临床试验
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列明Amo Manufacturing USA, LLC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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