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FDA 510(k)

EYEREVE (hioxifilcon D) 软性（亲水性）隐形眼镜，每日佩戴

K号: K161124 · 2016-08-26

申请人Vision Science Co., Ltd.
决定日期2016-08-26
产品代码LPL
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决定实质等同

器械摘要

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is the device name listed in this FDA 510(k) record. The listed applicant is Vision Science Co., Ltd.. It received FDA 510(k) clearance on 2016-08-26 under 510(k) number K161124. The device is classified under product code LPL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear?

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is a medical device that received FDA 510(k) clearance on 2016-08-26. The listed applicant is Vision Science Co., Ltd.. The 510(k) number is K161124.

When did EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear receive FDA 510(k) clearance?

EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear received FDA 510(k) clearance on 2016-08-26, under 510(k) number K161124.

Who is the listed applicant for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear?

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

What is the FDA product code for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear?

The FDA product code for EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear is LPL.

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：LPL）

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。

K262495Miru 1day UpSide (midafilcon A)Menicon Co, Ltd.K260507Interojo 45（inofilcon A）软（亲水性）硅凝胶隐形眼镜，带GrabSoo PlusINTEROJO, Inc.K253352Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Polymacon) Color Soft (Hydrophilic) Contact LensesPegavision CorporationK261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision CorporationK253885PUSCON 水平衡-1日着色（omafilcon A）软（亲水性）隐形眼镜；PUSCON 水平衡-1日着色（omafilcon A）软（亲水性）隐形眼镜GEO MEDICAL CO., LTD.K254269Saview SH Optic 38 UV (Senofilcon A) 可见度着色软性（亲水性）隐形眼镜；Saview SH Optic 38 UV 角膜散光（Senofilcon A）可见度着色软性（亲水性）隐形眼镜；Saview SH Optic 38 UV 多焦点（Senofilcon A）可见度着色软性（亲水性）隐形眼镜St. shine Optical Co., Ltd.

官方来源

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