FDA 510(k)

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)

K号: K162223 · 2017-01-04

决定日期2017-01-04

产品代码LPL

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决定实质等同

器械摘要

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) is the device name listed in this FDA 510(k) record. The listed applicant is Supervision Optimax Sdn Bhd. It received FDA 510(k) clearance on 2017-01-04 under 510(k) number K162223. 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 Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)?

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) is a medical device that received FDA 510(k) clearance on 2017-01-04. The listed applicant is Supervision Optimax Sdn Bhd. The 510(k) number is K162223.

When did Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) receive FDA 510(k) clearance?

Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) received FDA 510(k) clearance on 2017-01-04, under 510(k) number K162223.

Who is the listed applicant for Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)?

The FDA 510(k) record lists Supervision Optimax Sdn Bhd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)?

The FDA product code for Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A) is LPL.

列明Supervision Optimax Sdn Bhd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。

K180985Aveo (omafilcon A) 软性（亲水性）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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