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FDA 510(k)

Phoenix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）

K号: K231123 · 2023-08-30

申请人Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.
决定日期2023-08-30
产品代码LRX
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

Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) is the device name listed in this FDA 510(k) record. The listed applicant is Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.. It received FDA 510(k) clearance on 2023-08-30 under 510(k) number K231123. 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 Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)?

Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) is a medical device that received FDA 510(k) clearance on 2023-08-30. The listed applicant is Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.. The 510(k) number is K231123.

When did Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) receive FDA 510(k) clearance?

Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) received FDA 510(k) clearance on 2023-08-30, under 510(k) number K231123.

Who is the listed applicant for Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)?

The FDA 510(k) record lists Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03)?

The FDA product code for Phoenix Contact Lens Case - dome top flat pack (CL-01); Phoenix Contact Lens Case - classic flat pack (CL-02); Phoenix Contact Lens Case - sunglass shape flat pack (CL-03) 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

列明Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.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。

K201032Phoenix数字体温计

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.K240095CAREUS 接触镜盒（型号 1，型号 2，型号 3，型号 4，型号 5，型号 6）Shanghai Care US Medical Product Co., 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

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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