FEMTO LDV Z8飞秒激光手术仪
K号: K213559 · 2022-04-21
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决定日期2022-04-21
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
FEMTO LDV Z8 Femtosecond Surgical Laser is the device name listed in this FDA 510(k) record. The listed applicant is Sie Ag,Surgical Instrument Engineering. It received FDA 510(k) clearance on 2022-04-21 under 510(k) number K213559. 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 FEMTO LDV Z8 Femtosecond Surgical Laser?
FEMTO LDV Z8 Femtosecond Surgical Laser is a medical device that received FDA 510(k) clearance on 2022-04-21. The listed applicant is Sie Ag,Surgical Instrument Engineering. The 510(k) number is K213559.
When did FEMTO LDV Z8 Femtosecond Surgical Laser receive FDA 510(k) clearance?
FEMTO LDV Z8 Femtosecond Surgical Laser received FDA 510(k) clearance on 2022-04-21, under 510(k) number K213559.
Who is the listed applicant for FEMTO LDV Z8 Femtosecond Surgical Laser?
The FDA 510(k) record lists Sie Ag,Surgical Instrument Engineering as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for FEMTO LDV Z8 Femtosecond Surgical Laser?
The FDA product code for FEMTO LDV Z8 Femtosecond Surgical Laser is OOE.
相关临床试验
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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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