FDA 510(k)

Optimum Infinite (tisilfocon A) 每日佩戴隐形眼镜

K号: K212631 · 2022-03-17

决定日期2022-03-17

产品代码HQD

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决定实质等同

器械摘要

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses is the device name listed in this FDA 510(k) record. The listed applicant is Contamac, Ltd.. It received FDA 510(k) clearance on 2022-03-17 under 510(k) number K212631. 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 Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses?

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses is a medical device that received FDA 510(k) clearance on 2022-03-17. The listed applicant is Contamac, Ltd.. The 510(k) number is K212631.

When did Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses receive FDA 510(k) clearance?

Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses received FDA 510(k) clearance on 2022-03-17, under 510(k) number K212631.

Who is the listed applicant for Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses?

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

What is the FDA product code for Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses?

The FDA product code for Optimum Infinite (tisilfocon A) Daily Wear Contact Lenses is HQD.

列明Contamac, 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。

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查看所有 8 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 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

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