LENSAR 激光系统 - fs 3D (LLS-fs 3D)
K号: K173346 · 2018-03-02
广告
申请人Lensar, Inc.
决定日期2018-03-02
产品代码OOE
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
LENSAR Laser System - fs 3D (LLS-fs 3D) is the device name listed in this FDA 510(k) record. The listed applicant is Lensar, Inc.. It received FDA 510(k) clearance on 2018-03-02 under 510(k) number K173346. 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 LENSAR Laser System - fs 3D (LLS-fs 3D)?
LENSAR Laser System - fs 3D (LLS-fs 3D) is a medical device that received FDA 510(k) clearance on 2018-03-02. The listed applicant is Lensar, Inc.. The 510(k) number is K173346.
When did LENSAR Laser System - fs 3D (LLS-fs 3D) receive FDA 510(k) clearance?
LENSAR Laser System - fs 3D (LLS-fs 3D) received FDA 510(k) clearance on 2018-03-02, under 510(k) number K173346.
Who is the listed applicant for LENSAR Laser System - fs 3D (LLS-fs 3D)?
The FDA 510(k) record lists Lensar, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LENSAR Laser System - fs 3D (LLS-fs 3D)?
The FDA product code for LENSAR Laser System - fs 3D (LLS-fs 3D) is OOE.
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Lensar, 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。
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。
广告