FDA 510(k)

Iridex 532激光；Iridex 577激光；Iridex激光（532 nm和577 nm型号）

K号: K230228 · 2023-02-23

决定日期2023-02-23

产品代码HQF

咨询委员会OP 请注意，由于您没有提供具体的医疗设备监管文本，我无法进行翻译。请提供具体的文本内容，以便我能够按照您的要求进行翻译。

决定实质等同

器械摘要

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corporation. It received FDA 510(k) clearance on 2023-02-23 under 510(k) number K230228. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)?

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) is a medical device that received FDA 510(k) clearance on 2023-02-23. The listed applicant is Iridex Corporation. The 510(k) number is K230228.

When did Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) receive FDA 510(k) clearance?

Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) received FDA 510(k) clearance on 2023-02-23, under 510(k) number K230228.

Who is the listed applicant for Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)?

The FDA 510(k) record lists Iridex Corporation as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models)?

The FDA product code for Iridex 532 Laser; Iridex 577 Laser; Iridex Laser (532 nm and 577 nm models) is HQF.

列明Iridex Corporation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。

K223132Iridex PASCAL® 532，Iridex PASCAL® 577，Iridex PASCAL®（532nm和577 nm型号）K213592Iridex 810激光 K202760Iridex 810激光 K181662Iridex TruFocus LIO Premiere K170718Iridex TruFocus LIO Premiere K162416IRIDEX Cyclo G6 Laser System, G-Probe Illuminate

查看所有 7 个设备 →

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。