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FDA 510(k)

Acuity 200® (氟氧非孔素A) 硬性透气性隐形眼镜；Acuity 100® (六氟非孔素A) 硬性透气性隐形眼镜；Acuity 200® 配 Tangible® Hydra-PEG® (氟氧非孔素A) 硬性透气性隐形眼镜；Acuity 100® 配 Tangible® Hydra-PEG® (六氟非孔素A) 硬性透气性隐形眼镜

K号: K240618 · 2024-04-03

申请人Acuity Polymers, Inc.
决定日期2024-04-03
产品代码HQD
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决定实质等同

器械摘要

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Acuity Polymers, Inc.. It received FDA 510(k) clearance on 2024-04-03 under 510(k) number K240618. The device is classified under product code HQD. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens?

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens is a medical device that received FDA 510(k) clearance on 2024-04-03. The listed applicant is Acuity Polymers, Inc.. The 510(k) number is K240618.

When did Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens receive FDA 510(k) clearance?

Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens received FDA 510(k) clearance on 2024-04-03, under 510(k) number K240618.

Who is the listed applicant for Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens?

The FDA 510(k) record lists Acuity Polymers, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens?

The FDA product code for Acuity 200™ (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ (hexafocon A) Rigid Gas Permeable Contact Lens; Acuity 200™ with Tangible® Hydra-PEG® (fluoroxyfocon A) Rigid Gas Permeable Contact Lens; Acuity 100™ with Tangible® Hydra-PEG® (hexafocon A) Rigid Gas Permeable Contact Lens is HQD.

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Acuity Polymers, 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。

K242393Acuity 181™ (tisilfocon A) 和Acuity 181™ (tisilfocon A) 配有Tangible™ Hydra-PEG® 硬性透气性隐形眼镜K230965Acuity 100™ (hexafocon A) 配有Tangible™ Hydra-PEG®，TYRO™-97 (hofocon A) 配有Tangible™ Hydra-PEG® 硬性透气性隐形眼镜K213538Acuity 200 配有Tangible Hydra-PEG (fluoroxyfocon A) 硬性透气性隐形眼镜K203571Acuity 200 (fluoroxyfocon A) 硬性透气性隐形眼镜K201194Acuity 200™ (fluoroxyfocon A) 硬性透气性隐形眼镜K180988Acuity 18 (enflufocon A) 硬性透气性隐形眼镜，Acuity 58 (enflufocon B) 硬性透气性隐形眼镜，Acuity 85 (Oprifocon A) 硬性透气性隐形眼镜，Acuity 100 (hexafocon A) 硬性透气性隐形眼镜

查看所有 11 个设备 →

相关器械（代码：HQD）

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。

K253822GPA（六氟酮A）硬性透气性隐形眼镜Zhuhai Fitlens Medical Technology Co., Ltd.K242393Acuity 181™ (tisilfocon A) 和Acuity 181™ (tisilfocon A) 配有Tangible™ Hydra-PEG® 硬性透气性隐形眼镜Acuity Polymers, Inc.K241398SDJMASTERVISION (fluoroxyfocon A) 硬性透气性隐形眼镜Tianjin Mastervision Technology Co., Ltd.K241571BostonSight® 专业镜片Boston Foundation For Sight, Inc. D/B/A BostonsightK233325Visionary Optics 视觉光学 角膜接触镜（roflufocon D，roflufocon E，hexafocon A，hexafocon B，tisilfocon A，fluoroxyfocon A）Visionary Optics, LLCK230965Acuity 100™ (hexafocon A) 配有Tangible™ Hydra-PEG®，TYRO™-97 (hofocon A) 配有Tangible™ Hydra-PEG® 硬性透气性隐形眼镜Acuity Polymers, Inc.

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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