FDA 510(k)

Iridex PASCAL® 532，Iridex PASCAL® 577，Iridex PASCAL®（532nm和577 nm型号）

K号: K223132 · 2022-11-09

决定日期2022-11-09

产品代码HQF

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决定实质等同

器械摘要

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm 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 2022-11-09 under 510(k) number K223132. 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 PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)?

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) is a medical device that received FDA 510(k) clearance on 2022-11-09. The listed applicant is Iridex Corporation. The 510(k) number is K223132.

When did Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) receive FDA 510(k) clearance?

Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models) received FDA 510(k) clearance on 2022-11-09, under 510(k) number K223132.

Who is the listed applicant for Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm 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 PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm and 577 nm models)?

The FDA product code for Iridex PASCAL® 532, Iridex PASCAL® 577, Iridex PASCAL® (532nm 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。

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官方来源

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