RxSight® 插入装置
K号: K261174 · 2026-06-10
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决定日期2026-06-10
产品代码MSS
咨询委员会OP
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决定实质等同
器械摘要
RxSight® Insertion Device is the device name listed in this FDA 510(k) record. The listed applicant is Rxsight, Inc.. It received FDA 510(k) clearance on 2026-06-10 under 510(k) number K261174. The device is classified under product code MSS. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.
常见问题
What is the RxSight® Insertion Device?
RxSight® Insertion Device is a medical device that received FDA 510(k) clearance on 2026-06-10. The listed applicant is Rxsight, Inc.. The 510(k) number is K261174.
When did RxSight® Insertion Device receive FDA 510(k) clearance?
RxSight® Insertion Device received FDA 510(k) clearance on 2026-06-10, under 510(k) number K261174.
Who is the listed applicant for RxSight® Insertion Device?
The FDA 510(k) record lists Rxsight, Inc. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for RxSight® Insertion Device?
The FDA product code for RxSight® Insertion Device is MSS.
相关临床试验
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。
列明Rxsight, 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。
相关器械（代码：MSS）
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。
K252540ACCUJECT 注射器套装 2.1-1P (LP604590)Medicel AGK242389EyeGility™ Inserter for Preloaded enVista IOLsBausch & Lomb, IncorporatedK231106Accuject Refra Injector AR2900Medicel AGK231838RxSight® 插入装置 (63002)Rxsight, Inc.K231466RxSight 插入装置Rxsight, Inc.K212039CLAREON MONARCH IV IOL 输送系统Alcon Laboratories, Inc.
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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