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FDA 510(k)

二極雷射治療設備（DF-DIODE LASER-S1）

K 號：K241547 · 2024-08-13

申請人Weifang Dragonfly Electronics Technology Co., Ltd.
決定日期2024-08-13
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 Device (DF-DIODE LASER-S1) is the device name listed in this FDA 510(k) record. The listed applicant is Weifang Dragonfly Electronics Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-08-13 under 510(k) number K241547. 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 Device (DF-DIODE LASER-S1)?

Diode Laser Therapy Device (DF-DIODE LASER-S1) is a medical device that received FDA 510(k) clearance on 2024-08-13. The listed applicant is Weifang Dragonfly Electronics Technology Co., Ltd.. The 510(k) number is K241547.

When did Diode Laser Therapy Device (DF-DIODE LASER-S1) receive FDA 510(k) clearance?

Diode Laser Therapy Device (DF-DIODE LASER-S1) received FDA 510(k) clearance on 2024-08-13, under 510(k) number K241547.

Who is the listed applicant for Diode Laser Therapy Device (DF-DIODE LASER-S1)?

The FDA 510(k) record lists Weifang Dragonfly Electronics 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 Device (DF-DIODE LASER-S1)?

The FDA product code for Diode Laser Therapy Device (DF-DIODE LASER-S1) is GEX. This falls under the Gastroenterology category.

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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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