FDA 510(k)

UNICON水凝胶（Hioxifilcon A）软性（亲水性）隐形眼镜

K号: K191929 · 2019-09-17

决定日期2019-09-17

产品代码LPL

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决定实质等同

器械摘要

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Unicon Optical Co., Ltd.. It received FDA 510(k) clearance on 2019-09-17 under 510(k) number K191929. 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 UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is a medical device that received FDA 510(k) clearance on 2019-09-17. The listed applicant is Unicon Optical Co., Ltd.. The 510(k) number is K191929.

When did UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens receive FDA 510(k) clearance?

UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens received FDA 510(k) clearance on 2019-09-17, under 510(k) number K191929.

Who is the listed applicant for UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

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

What is the FDA product code for UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens?

The FDA product code for UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens is LPL.

列明Unicon Optical 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。

K241707OCuSOFT AMENITY® (linofilcon A) 每日一次性隐形眼镜，配备 HYDRASEAL®K213216Qualis (linofilcon A) Soft (Hydrophilic) Daily Wear Contact Lens K182734Unicon水凝胶与Unicon聚合物（etafilcon A）软性（亲水）每日一次性隐形眼镜

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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