FDA 510(k)

ACUVUE® OASYS MAX 1-DAY 隐形眼镜 (senofilcon A)

K号: K210930 · 2021-11-29

决定日期2021-11-29

产品代码LPL

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决定实质等同

器械摘要

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Vision Care, Inc.. It received FDA 510(k) clearance on 2021-11-29 under 510(k) number K210930. 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 ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)?

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) is a medical device that received FDA 510(k) clearance on 2021-11-29. The listed applicant is Johnson & Johnson Vision Care, Inc.. The 510(k) number is K210930.

When did ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) receive FDA 510(k) clearance?

ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) received FDA 510(k) clearance on 2021-11-29, under 510(k) number K210930.

Who is the listed applicant for ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)?

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

What is the FDA product code for ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A)?

The FDA product code for ACUVUE® OASYS MAX 1-DAY Contact Lenses (senofilcon A) is LPL.

列明Johnson & Johnson Vision Care, 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。

K200243ACUVUE (senofilcon A) 软性隐形眼镜多焦点 K180299ACUVUE OASYS (senofilcon A) 含光致变色添加剂 K160212ACUVUE (senofilcon C) 软性隐形眼镜

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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