FDA 510(k)

二極雷射治療系統

K 號：K212978 · 2021-11-10

決定日期2021-11-10

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

Diode laser therapy system is the device name listed in this FDA 510(k) record. The listed applicant is Beijing Unt Technology Co., Ltd.. It received FDA 510(k) clearance on 2021-11-10 under 510(k) number K212978. 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 Diode laser therapy system?

Diode laser therapy system is a medical device that received FDA 510(k) clearance on 2021-11-10. The listed applicant is Beijing Unt Technology Co., Ltd.. The 510(k) number is K212978.

When did Diode laser therapy system receive FDA 510(k) clearance?

Diode laser therapy system received FDA 510(k) clearance on 2021-11-10, under 510(k) number K212978.

Who is the listed applicant for Diode laser therapy system?

The FDA 510(k) record lists Beijing Unt Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Diode laser therapy system?

The FDA product code for Diode laser therapy system is GEX. This falls under the Gastroenterology category.

其他以 Beijing Unt Technology Co., Ltd. 為申請人之記錄

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K232532奈秒YAG雷射治療系統

相關器械（代碼：GEX）

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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官方來源

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