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FDA 510(k)

Alcon（赛拉氟酮A）软性隐形眼镜，每日佩戴

K号: K212806 · 2021-12-28

申请人Alcon Laboratories, Inc.
决定日期2021-12-28
产品代码LPL
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决定实质等同

器械摘要

Alcon (serafilcon A) soft contact lenses for daily wear is the device name listed in this FDA 510(k) record. The listed applicant is Alcon Laboratories, Inc.. It received FDA 510(k) clearance on 2021-12-28 under 510(k) number K212806. 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 Alcon (serafilcon A) soft contact lenses for daily wear?

Alcon (serafilcon A) soft contact lenses for daily wear is a medical device that received FDA 510(k) clearance on 2021-12-28. The listed applicant is Alcon Laboratories, Inc.. The 510(k) number is K212806.

When did Alcon (serafilcon A) soft contact lenses for daily wear receive FDA 510(k) clearance?

Alcon (serafilcon A) soft contact lenses for daily wear received FDA 510(k) clearance on 2021-12-28, under 510(k) number K212806.

Who is the listed applicant for Alcon (serafilcon A) soft contact lenses for daily wear?

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

What is the FDA product code for Alcon (serafilcon A) soft contact lenses for daily wear?

The FDA product code for Alcon (serafilcon A) soft contact lenses 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

列明Alcon Laboratories, 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。

K254052DAILIES TOTAL1®; DAILIES TOTAL1® 多焦点K252682LenSx 激光系统（8065000944）K243896LenSx 激光系统（8065998162）K243909Precision1; Precision1 for Astigmatism; Dailies Total1; Dailies Total1 for Astigmatism; Dailies Total1 Multifocal; Dailies Total1 Multifocal ToricK242184Alcon 27GA Chandelier（8065000252）；Alcon 27+ DS广角内窥镜照明器（8065000253）；Alcon 27+ DS内窥镜照明器（8065000256）；K233876UNITY VCS（8065000296）；UNITY CS（8065000297）

查看所有 37 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.

官方来源

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