FDA 510(k)

Samfilcon B定制隐形眼镜

K号: K230954 · 2023-11-17

决定日期2023-11-17

产品代码LPL

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决定实质等同

器械摘要

Samfilcon B Custom Contact Lens is the device name listed in this FDA 510(k) record. The listed applicant is Bausch + Lomb, Incorporated. It received FDA 510(k) clearance on 2023-11-17 under 510(k) number K230954. 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 Samfilcon B Custom Contact Lens?

Samfilcon B Custom Contact Lens is a medical device that received FDA 510(k) clearance on 2023-11-17. The listed applicant is Bausch + Lomb, Incorporated. The 510(k) number is K230954.

When did Samfilcon B Custom Contact Lens receive FDA 510(k) clearance?

Samfilcon B Custom Contact Lens received FDA 510(k) clearance on 2023-11-17, under 510(k) number K230954.

Who is the listed applicant for Samfilcon B Custom Contact Lens?

The FDA 510(k) record lists Bausch + Lomb, Incorporated as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Samfilcon B Custom Contact Lens?

The FDA product code for Samfilcon B Custom Contact Lens is LPL.

列明Bausch + Lomb, Incorporated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。

K211786独立角膜观察室（IVC-21）K200528Bausch + Lomb（Kalifilcon A）软性隐形眼镜，Bausch + Lomb（Kalifilcon A）软性隐形眼镜用于散光 K171404BOSTON XO (hexafocon A), BOSTON XO2 (hexafocon B)

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.

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