FDA 510(k)

アイリデックス・トゥーフォーカス・LIO プレミアム

K番号: K170718 · 2017-05-03

決定日2017-05-03

製品コードGEX

諮問委員会SU （以下のテキストは翻訳されていません。） Policy: medical-regulatory-v1

決定大幅同等

医療機器の概要

Iridex TruFocus LIO Premiere is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corporation. It received FDA 510(k) clearance on 2017-05-03 under 510(k) number K170718. The device is classified under product code GEX. It was reviewed by the SU advisory panel. Product code GEX falls under the category of Gastroenterology, which includes gastrointestinal diagnostic and therapeutic devices. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

よくある質問

What is the Iridex TruFocus LIO Premiere?

Iridex TruFocus LIO Premiere is a medical device that received FDA 510(k) clearance on 2017-05-03. The listed applicant is Iridex Corporation. The 510(k) number is K170718.

When did Iridex TruFocus LIO Premiere receive FDA 510(k) clearance?

Iridex TruFocus LIO Premiere received FDA 510(k) clearance on 2017-05-03, under 510(k) number K170718.

Who is the listed applicant for Iridex TruFocus LIO Premiere?

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 TruFocus LIO Premiere?

The FDA product code for Iridex TruFocus LIO Premiere is GEX. This falls under the Gastroenterology category.

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