FDA 510(k)

定制稳定刚性透气性角巩膜接触镜

K号: K213880 · 2022-01-07

决定日期2022-01-07

产品代码HQD

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决定实质等同

器械摘要

Custom Stable Rigid Gas Permeable Scleral Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Valley Contax, Inc.. It received FDA 510(k) clearance on 2022-01-07 under 510(k) number K213880. 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 Custom Stable Rigid Gas Permeable Scleral Contact Lens?

Custom Stable Rigid Gas Permeable Scleral Contact Lens is a medical device that received FDA 510(k) clearance on 2022-01-07. The listed applicant is Valley Contax, Inc.. The 510(k) number is K213880.

When did Custom Stable Rigid Gas Permeable Scleral Contact Lens receive FDA 510(k) clearance?

Custom Stable Rigid Gas Permeable Scleral Contact Lens received FDA 510(k) clearance on 2022-01-07, under 510(k) number K213880.

Who is the listed applicant for Custom Stable Rigid Gas Permeable Scleral Contact Lens?

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

What is the FDA product code for Custom Stable Rigid Gas Permeable Scleral Contact Lens?

The FDA product code for Custom Stable Rigid Gas Permeable Scleral Contact Lens is HQD.

列明Valley Contax, 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。

K202860Valley Contax 单焦距（SV）透气性隐形眼镜（roflufocon D，roflufocon E，tisilfocon A，hexafocon A，enflufocon A），Valley Contax 金眼非球面多焦点（AFM）透气性隐形眼镜（roflufocon D，roflufocon E，tisilfocon A，hexafocon A，enflufocon A），Valley Contax V Kone（VK）透气性隐形眼镜（roflufocon D，roflufocon E，tisilfocon A，hexafocon A，enflufocon A）K170335Custom Stable™ 刚性透气性角巩膜接触镜

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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