FDA 510(k)

Ampleye 角膜 RGP 镜（roflufocon D，roflufocon E，hexafocon A，paflufocon D）

K号: K172314 · 2017-09-20

决定日期2017-09-20

产品代码HQD

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决定实质等同

器械摘要

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is the device name listed in this FDA 510(k) record. The listed applicant is Art Optical Contact Lens, Inc.. It received FDA 510(k) clearance on 2017-09-20 under 510(k) number K172314. 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 Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)?

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is a medical device that received FDA 510(k) clearance on 2017-09-20. The listed applicant is Art Optical Contact Lens, Inc.. The 510(k) number is K172314.

When did Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) receive FDA 510(k) clearance?

Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) received FDA 510(k) clearance on 2017-09-20, under 510(k) number K172314.

Who is the listed applicant for Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)?

The FDA 510(k) record lists Art Optical Contact Lens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D)?

The FDA product code for Ampleye Scleral RGP Lens (roflufocon D, roflufocon E, hexafocon A, paflufocon D) is HQD.

列明Art Optical Contact Lens, 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。

K230824IntelliWave3，硅水凝胶日戴软性隐形眼镜（efrofilcon A）

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 Bostonsight K240618Acuity 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, LLC

官方来源

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