免责声明: 本站汇总 FDA、ClinicalTrials.gov、PubMed、SEC EDGAR 等官方公开数据，仅供一般参考，不构成医疗建议、诊断、治疗建议或投资建议。

FDA 510(k)

EVA NEXUS 眼科手术系统

K号: K213467 · 2022-06-14

申请人D.O.R.C. Dutch Ophthalmic Research Center (International)
决定日期2022-06-14
产品代码HQC
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

EVA NEXUS Ophthalmic Surgical System is the device name listed in this FDA 510(k) record. The listed applicant is D.O.R.C. Dutch Ophthalmic Research Center (International). It received FDA 510(k) clearance on 2022-06-14 under 510(k) number K213467. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EVA NEXUS Ophthalmic Surgical System?

EVA NEXUS Ophthalmic Surgical System is a medical device that received FDA 510(k) clearance on 2022-06-14. The listed applicant is D.O.R.C. Dutch Ophthalmic Research Center (International). The 510(k) number is K213467.

When did EVA NEXUS Ophthalmic Surgical System receive FDA 510(k) clearance?

EVA NEXUS Ophthalmic Surgical System received FDA 510(k) clearance on 2022-06-14, under 510(k) number K213467.

Who is the listed applicant for EVA NEXUS Ophthalmic Surgical System?

The FDA 510(k) record lists D.O.R.C. Dutch Ophthalmic Research Center (International) as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EVA NEXUS Ophthalmic Surgical System?

The FDA product code for EVA NEXUS Ophthalmic Surgical System is HQC.

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。

NCT07608549FLASHPilot 1期安全性研究NOT_YET_RECRUITINGNCT06562205PAP系统外部临床研究（ECS）NOT_YET_RECRUITINGNCT06443177交感神经调节对动脉瘤性蛛网膜下腔出血继发脑动脉痉挛的影响SUSPENDEDNCT07095751人工智能辅助尿路摄像头评估系统，用于诊断膀胱癌NOT_YET_RECRUITING

列明D.O.R.C. Dutch Ophthalmic Research Center (International)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。

K190875EVA，前部机器，EVA，组合机器，EVA组合机器带激光（DORC连接器），EVA组合机器带激光（SMA连接器）

相关器械（代码：HQC）

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。

K261264Stellaris Elite™视觉增强系统；后部和联合手术包：23号后部Elite™包(SE5423)；23号双刀片™玻璃体切割器后部Stellaris Elite™包(SE5423B)；25号后部Elite™包(SE5425)；25号双刀片™玻璃体切割器后部Stellaris Elite™包(SE5425B)；27号双刀片™玻璃体切割器后部Stellaris Elite™包(SE5427B)；23号双刀片™+玻璃体切割器后部Stellaris Elite™包(SE5423BB+)Bausch and LombK252052Stellaris Elite™视觉增强系统(BL11145, BL14455, BL15455, SE14565, SE15565, SE14565E, SE15565E)Bausch and Lomb, IncorporatedK250501System SophiThis AGK243395MICOR 700 自动 I/ACarl Zeiss Meditec Cataract Technology, Inc.K242801MICOR 700 系统 (N/A)；MICOR 700 驱动器 (FG-50631)；MICOR 700 提取器 (FG-50621)；MICOR 700 视网膜剪刀 (FG-51185)Carl Zeiss Meditec Cataract Technology, Inc.K240169Stellaris Elite视觉增强系统(BL11145, BL14455, BL15455)Bausch and Lomb, Incorporated

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。

↑