FDA 510(k)

ELITA™ 激光系统，ELITA™ 患者界面

K号: K223566 · 2023-04-14

申请人Johnson & Johnson Surgical Vision, Inc.

决定日期2023-04-14

产品代码OOE

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决定实质等同

器械摘要

ELITA™ Femtosecond Laser System, ELITA™ Patient Interface is the device name listed in this FDA 510(k) record. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. It received FDA 510(k) clearance on 2023-04-14 under 510(k) number K223566. The device is classified under product code OOE. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the ELITA™ Femtosecond Laser System, ELITA™ Patient Interface?

ELITA™ Femtosecond Laser System, ELITA™ Patient Interface is a medical device that received FDA 510(k) clearance on 2023-04-14. The listed applicant is Johnson & Johnson Surgical Vision, Inc.. The 510(k) number is K223566.

When did ELITA™ Femtosecond Laser System, ELITA™ Patient Interface receive FDA 510(k) clearance?

ELITA™ Femtosecond Laser System, ELITA™ Patient Interface received FDA 510(k) clearance on 2023-04-14, under 510(k) number K223566.

Who is the listed applicant for ELITA™ Femtosecond Laser System, ELITA™ Patient Interface?

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

What is the FDA product code for ELITA™ Femtosecond Laser System, ELITA™ Patient Interface?

The FDA product code for ELITA™ Femtosecond Laser System, ELITA™ Patient Interface is OOE.

列明Johnson & Johnson Surgical 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。

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官方来源

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