FDA 510(k)

ZeptoLink人工晶状体定位系统

K号: K223763 · 2023-04-11

决定日期2023-04-11

产品代码PUL

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决定实质等同

器械摘要

ZeptoLink IOL Positioning System is the device name listed in this FDA 510(k) record. The listed applicant is Centricity Vision, Inc.. It received FDA 510(k) clearance on 2023-04-11 under 510(k) number K223763. The device is classified under product code PUL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ZeptoLink IOL Positioning System?

ZeptoLink IOL Positioning System is a medical device that received FDA 510(k) clearance on 2023-04-11. The listed applicant is Centricity Vision, Inc.. The 510(k) number is K223763.

When did ZeptoLink IOL Positioning System receive FDA 510(k) clearance?

ZeptoLink IOL Positioning System received FDA 510(k) clearance on 2023-04-11, under 510(k) number K223763.

Who is the listed applicant for ZeptoLink IOL Positioning System?

The FDA 510(k) record lists Centricity Vision, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZeptoLink IOL Positioning System?

The FDA product code for ZeptoLink IOL Positioning System is PUL.

列明Centricity Vision, 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。

K221188ZEPTO 精密囊外切除术系统 K210827ZEPTO 精密囊外切除术系统

官方来源

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