FDA 510(k)

Menicon ASRB (asmofilcon A) 硅胶软性隐形眼镜

K号: K180004 · 2018-02-22

决定日期2018-02-22

产品代码LPL

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决定实质等同

器械摘要

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Menicon Co, Ltd.. It received FDA 510(k) clearance on 2018-02-22 under 510(k) number K180004. 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 Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens?

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is a medical device that received FDA 510(k) clearance on 2018-02-22. The listed applicant is Menicon Co, Ltd.. The 510(k) number is K180004.

When did Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens receive FDA 510(k) clearance?

Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens received FDA 510(k) clearance on 2018-02-22, under 510(k) number K180004.

Who is the listed applicant for Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens?

FDA 510(k)记录将美尼康株式会社（Menicon Co, Ltd.）列为申请人。这本身并不足以确立该设备的制造商。

What is the FDA product code for Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens?

The FDA product code for Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens is LPL.

列明Menicon 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。

K262495Miru 1day UpSide (midafilcon A)K253795美尼塞普3%过氧化氢清洁与消毒溶液 K193399Miru 1day UpSide (midafilcon A)K191872Menicon 3% 过氧化氢清洁和消毒溶液 K180819One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens K173136Menicon Progent 蛋白质去除剂，用于硬性透气性隐形眼镜

查看所有 7 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 Corporation K261299Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses; Pegavision (Toufilcon B) Soft (Hydrophilic) Contact LensesPegavision Corporation K253885PUSCON 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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