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FDA 510(k)

Largan U38 (Polymacon) 每日佩戴软性（亲水性）隐形眼镜，Largan U38 (Polymacon) 每日佩戴软性（亲水性）隐形眼镜用于散光，Largan U38 (Polymacon) 每日佩戴软性（亲水性）隐形眼镜用于老花眼

K号: K182674 · 2018-11-13

申请人Largan Medical Co., Ltd.
决定日期2018-11-13
产品代码LPL
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决定实质等同

器械摘要

Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is the device name listed in this FDA 510(k) record. The listed applicant is Largan Medical Co., Ltd.. It received FDA 510(k) clearance on 2018-11-13 under 510(k) number K182674. 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 Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia?

Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia is a medical device that received FDA 510(k) clearance on 2018-11-13. The listed applicant is Largan Medical Co., Ltd.. The 510(k) number is K182674.

When did Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia receive FDA 510(k) clearance?

Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia received FDA 510(k) clearance on 2018-11-13, under 510(k) number K182674.

Who is the listed applicant for Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia?

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

What is the FDA product code for Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia?

The FDA product code for Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan U38 (Polymacon) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia 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

列明Largan Medical Co., 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。

K242916Largan U38 Color (Polymacon) 每日佩戴软性（亲水性）隐形眼镜K233501“拉根健康AI科技”睡眠呼吸暂停及睡眠质量检测系统（ST-SLP03A）K202129Largan DB / DB Color (ocufilcon D) 每日佩戴软性（亲水性）隐形眼镜，Largan DB / DB Color (ocufilcon D) 每日佩戴软性（亲水性）隐形眼镜用于散光，Largan DB / DB Color (ocufilcon D) 每日佩戴软性（亲水性）隐形眼镜用于老花眼K182523Largan 55 UV Color (Ocufilcon D) 每日佩戴软性（亲水性）隐形眼镜K181232Largan 55 UV (ocufilcon D) 每日佩戴软性（亲水性）隐形眼镜，Largan 55 UV (ocufilcon D) 每日佩戴软性（亲水性）隐形眼镜用于散光，Largan 55 UV (ocufilcon D) 每日佩戴软性（亲水性）隐形眼镜用于老花眼K181230Largan 55 (methafilcon A) 每日佩戴软性（亲水性）隐形眼镜，Largan 55 (methafilcon A) 每日佩戴软性（亲水性）隐形眼镜用于散光，Largan 55 (methafilcon A) 每日佩戴软性（亲水性）隐形眼镜用于老花眼

查看所有 8 个设备 →

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.

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