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FDA 510(k)

OxyAqua（olifilcon D）球面硅水凝胶软性隐形眼镜，OxyAqua（olifilcon D）多焦点硅水凝胶软性隐形眼镜，OxyAqua（olifilcon D）散光硅水凝胶软性隐形眼镜

K号: K173958 · 2018-04-03

申请人Visco Vision, Inc.
决定日期2018-04-03
产品代码LPL
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决定实质等同

器械摘要

OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens is the device name listed in this FDA 510(k) record. The listed applicant is Visco Vision, Inc.. It received FDA 510(k) clearance on 2018-04-03 under 510(k) number K173958. 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 OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens?

OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens is a medical device that received FDA 510(k) clearance on 2018-04-03. The listed applicant is Visco Vision, Inc.. The 510(k) number is K173958.

When did OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens receive FDA 510(k) clearance?

OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens received FDA 510(k) clearance on 2018-04-03, under 510(k) number K173958.

Who is the listed applicant for OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens?

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

What is the FDA product code for OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens?

The FDA product code for OxyAqua (olifilcon D) spherical silicone hydrogel soft contact lens, OxyAqua (olifilcon D) multifocal silicone hydrogel soft contact lens, OxyAqua (olifilcon D) toric silicone hydrogel soft contact lens 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Visco Vision, 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。

K200618HydroSens A (hioxifilcon A) 球形水凝胶软性隐形眼镜K201080Daily Breeze B（olifilcon B）球面硅水凝胶软性隐形眼镜，Daily Breeze B（olifilcon B）散光硅水凝胶软性隐形眼镜，Daily Breeze B（olifilcon B）多焦点硅水凝胶软性隐形眼镜K191397OxySoft (olifilcon C) 硅凝胶软性隐形眼镜K183670Vexillum Zephyr（olifilcon A）带实体聚合物球面/散光/多焦点硅水凝胶软性隐形眼镜；OxyPure A（olifilcon A）球面/散光/多焦点硅水凝胶软性隐形眼镜K181349Vexillum（olifilcon B）与实体聚合物硅凝胶软性隐形眼镜；Daily Breeze（olifilcon B）硅凝胶软性隐形眼镜K180322Si-Hy（olifilcon B）彩色硅凝胶软性隐形眼镜

查看所有 10 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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