FDA 510(k)

ZEPTO 精密囊外切除术系统

K号: K221188 · 2022-06-23

决定日期2022-06-23

产品代码PUL

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决定实质等同

器械摘要

ZEPTO Precision Capsulotomy 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 2022-06-23 under 510(k) number K221188. 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 ZEPTO Precision Capsulotomy System?

ZEPTO Precision Capsulotomy System is a medical device that received FDA 510(k) clearance on 2022-06-23. The listed applicant is Centricity Vision, Inc.. The 510(k) number is K221188.

When did ZEPTO Precision Capsulotomy System receive FDA 510(k) clearance?

ZEPTO Precision Capsulotomy System received FDA 510(k) clearance on 2022-06-23, under 510(k) number K221188.

Who is the listed applicant for ZEPTO Precision Capsulotomy 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 ZEPTO Precision Capsulotomy System?

The FDA product code for ZEPTO Precision Capsulotomy 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。

K223763ZeptoLink人工晶状体定位系统 K210827ZEPTO 精密囊外切除术系统

官方来源

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