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FDA 510(k)

CAREUS 接触镜盒（型号 1，型号 2，型号 3，型号 4，型号 5，型号 6）

K号: K240095 · 2024-10-09

申请人Shanghai Care US Medical Product Co., Ltd.
决定日期2024-10-09
产品代码LRX
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决定实质等同

器械摘要

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) is the device name listed in this FDA 510(k) record. The listed applicant is Shanghai Care US Medical Product Co., Ltd.. It received FDA 510(k) clearance on 2024-10-09 under 510(k) number K240095. The device is classified under product code LRX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)?

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) is a medical device that received FDA 510(k) clearance on 2024-10-09. The listed applicant is Shanghai Care US Medical Product Co., Ltd.. The 510(k) number is K240095.

When did CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) receive FDA 510(k) clearance?

CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) received FDA 510(k) clearance on 2024-10-09, under 510(k) number K240095.

Who is the listed applicant for CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)?

The FDA 510(k) record lists Shanghai Care US Medical Product Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6)?

The FDA product code for CAREUS Contact Lens Case (Model 1, Model 2, Model 3, Model 4, Model 5, Model 6) is LRX.

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

相关器械（代码：LRX）

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。

K252175LANDR 接触镜盒Fourth Axis, LLCK250495MINI VP1 (PL67_F); MINI VP1 (PL61_F)Avizor S.A.K231123Phoenix隐形眼镜盒 - 圆顶顶部扁平包装（CL-01）；Phoenix隐形眼镜盒 - 经典扁平包装（CL-02）；Phoenix隐形眼镜盒 - 太阳镜形状扁平包装（CL-03）Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.K173538Clear Care 清洁与消毒溶液，AOCup 镜盒带 AODiscAlcon Laboratories, Inc.K172925隐形眼镜盒，型号：A-1，B-1P L Overseas LimitedK173365Bausch + Lomb Boston 角膜塑形镜盒Bausch & Lomb, Incorporated

官方来源

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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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