FDA 510(k)

IRIDEX 過濾光 G6 激光系統，G-Probe 照明

K 號：K162416 · 2016-09-29

決定日期2016-09-29

產品代碼GEX

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is the device name listed in this FDA 510(k) record. The listed applicant is Iridex Corporation. It received FDA 510(k) clearance on 2016-09-29 under 510(k) number K162416. 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.

常見問題

What is the IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is a medical device that received FDA 510(k) clearance on 2016-09-29. The listed applicant is Iridex Corporation. The 510(k) number is K162416.

When did IRIDEX Cyclo G6 Laser System, G-Probe Illuminate receive FDA 510(k) clearance?

IRIDEX Cyclo G6 Laser System, G-Probe Illuminate received FDA 510(k) clearance on 2016-09-29, under 510(k) number K162416.

Who is the listed applicant for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate?

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 Cyclo G6 Laser System, G-Probe Illuminate?

The FDA product code for IRIDEX Cyclo G6 Laser System, G-Probe Illuminate is GEX. This falls under the Gastroenterology category.

其他以 Iridex Corporation 為申請人之記錄

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相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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