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FDA 510(k)

GPA（六氟酮A）硬性透气性隐形眼镜

K号: K253822 · 2026-03-27

申请人Zhuhai Fitlens Medical Technology Co., Ltd.
决定日期2026-03-27
产品代码HQD
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决定实质等同

器械摘要

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Zhuhai Fitlens Medical Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-03-27 under 510(k) number K253822. 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 GPA (hexafocon A) Rigid Gas Permeable Contact Lenses?

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses is a medical device that received FDA 510(k) clearance on 2026-03-27. The listed applicant is Zhuhai Fitlens Medical Technology Co., Ltd.. The 510(k) number is K253822.

When did GPA (hexafocon A) Rigid Gas Permeable Contact Lenses receive FDA 510(k) clearance?

GPA (hexafocon A) Rigid Gas Permeable Contact Lenses received FDA 510(k) clearance on 2026-03-27, under 510(k) number K253822.

Who is the listed applicant for GPA (hexafocon A) Rigid Gas Permeable Contact Lenses?

The FDA 510(k) record lists Zhuhai Fitlens Medical Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for GPA (hexafocon A) Rigid Gas Permeable Contact Lenses?

The FDA product code for GPA (hexafocon A) Rigid Gas Permeable Contact Lenses 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

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。

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 BostonsightK240618Acuity 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Acuity Polymers, Inc.K233325Visionary 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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