FDA 510(k)

TearCare MGX 系统泪液护理系统

K号: K231084 · 2023-12-27

决定日期2023-12-27

产品代码ORZ

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决定实质等同

器械摘要

TearCare MGX System is the device name listed in this FDA 510(k) record. The listed applicant is Sight Sciences, Inc.. It received FDA 510(k) clearance on 2023-12-27 under 510(k) number K231084. The device is classified under product code ORZ. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the TearCare MGX System?

TearCare MGX System is a medical device that received FDA 510(k) clearance on 2023-12-27. The listed applicant is Sight Sciences, Inc.. The 510(k) number is K231084.

When did TearCare MGX System receive FDA 510(k) clearance?

TearCare MGX System received FDA 510(k) clearance on 2023-12-27, under 510(k) number K231084.

Who is the listed applicant for TearCare MGX System?

FDA 510(k)记录中列出Sight Sciences, Inc.为申请人。这本身并不能确立该设备制造商的身份。

What is the FDA product code for TearCare MGX System?

The FDA product code for TearCare MGX System is ORZ.

列明Sight Sciences, 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。

K262479TearCare 系统 K253760OMNI超手术系统（1-110）K252409TearCare MGX 系统泪液护理系统 K242786TearCare MGX 系统泪液护理系统 K232214OMNI Surgical System K213045TearCare 系统

查看所有 11 个设备 →

官方来源

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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。