ALLY自适应白内障治疗系统
K号: K220259 · 2022-06-09
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申请人Lensar, Inc.
决定日期2022-06-09
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
ALLY Adaptive Cataract Treatment System is the device name listed in this FDA 510(k) record. The listed applicant is Lensar, Inc.. It received FDA 510(k) clearance on 2022-06-09 under 510(k) number K220259. 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 ALLY Adaptive Cataract Treatment System?
ALLY Adaptive Cataract Treatment System is a medical device that received FDA 510(k) clearance on 2022-06-09. The listed applicant is Lensar, Inc.. The 510(k) number is K220259.
When did ALLY Adaptive Cataract Treatment System receive FDA 510(k) clearance?
ALLY Adaptive Cataract Treatment System received FDA 510(k) clearance on 2022-06-09, under 510(k) number K220259.
Who is the listed applicant for ALLY Adaptive Cataract Treatment System?
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 ALLY Adaptive Cataract Treatment System?
The FDA product code for ALLY Adaptive Cataract Treatment System is OOE.
相关临床试验
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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, LLCK220516CATALYS 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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