FDA 510(k)

IntelliWave3，硅水凝胶日戴软性隐形眼镜（efrofilcon A）

K号: K230824 · 2023-09-06

决定日期2023-09-06

产品代码LPL

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决定实质等同

器械摘要

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is the device name listed in this FDA 510(k) record. The listed applicant is Art Optical Contact Lens, Inc.. It received FDA 510(k) clearance on 2023-09-06 under 510(k) number K230824. 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 IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)?

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is a medical device that received FDA 510(k) clearance on 2023-09-06. The listed applicant is Art Optical Contact Lens, Inc.. The 510(k) number is K230824.

When did IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) receive FDA 510(k) clearance?

IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) received FDA 510(k) clearance on 2023-09-06, under 510(k) number K230824.

Who is the listed applicant for IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)?

The FDA 510(k) record lists Art Optical Contact Lens, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A)?

The FDA product code for IntelliWave3, Silicone Hydrogel Daily Wear Soft Contact Lens (efrofilcon A) is LPL.

列明Art Optical Contact Lens, 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。

K172314Ampleye 角膜 RGP 镜（roflufocon D，roflufocon E，hexafocon A，paflufocon D）

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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