Bausch + Lomb Boston 角膜塑形镜盒
K号: K173365 · 2017-11-17
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决定日期2017-11-17
产品代码LRX
咨询委员会OP
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决定实质等同
器械摘要
Bausch + Lomb Boston Scleral Lens Case 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 2017-11-17 under 510(k) number K173365. The device is classified under product code LRX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the Bausch + Lomb Boston Scleral Lens Case?
Bausch + Lomb Boston Scleral Lens Case is a medical device that received FDA 510(k) clearance on 2017-11-17. The listed applicant is Bausch & Lomb, Incorporated. The 510(k) number is K173365.
When did Bausch + Lomb Boston Scleral Lens Case receive FDA 510(k) clearance?
Bausch + Lomb Boston Scleral Lens Case received FDA 510(k) clearance on 2017-11-17, under 510(k) number K173365.
Who is the listed applicant for Bausch + Lomb Boston Scleral Lens Case?
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 Bausch + Lomb Boston Scleral Lens Case?
The FDA product code for Bausch + Lomb Boston Scleral Lens Case is LRX.
相关临床试验
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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。
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相关器械（代码：LRX）
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。
K252175LANDR 接触镜盒Fourth Axis, LLCK250495MINI VP1 (PL67_F); MINI VP1 (PL61_F)Avizor S.A.K240095CAREUS 接触镜盒（型号 1，型号 2，型号 3，型号 4，型号 5，型号 6）Shanghai Care US Medical Product Co., Ltd.K231123Phoenix隐形眼镜盒 - 圆顶顶部扁平包装（CL-01）；Phoenix隐形眼镜盒 - 经典扁平包装（CL-02）；Phoenix隐形眼镜盒 - 太阳镜形状扁平包装（CL-03）Phoenix Innovative Healthcare Manufacturers Pvt. , Ltd.K173538Clear Care 清洁与消毒溶液，AOCup 镜盒带 AODiscAlcon Laboratories, Inc.K172925隐形眼镜盒，型号：A-1，B-1P L Overseas Limited
官方来源
在 FDA 数据库中查看 →数据来源于FDA开放API。如需最新且权威的信息，请务必参考官方记录。
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