FDA 510(k)

LED固化燈（DB686 HALO）

K 號：K243921 · 2025-04-11

申請人Foshan Coxo Medical Instrument Co., Ltd.

決定日期2025-04-11

產品代碼EBZ

諮詢委員會DE

決定相當於

器材摘要

LED Curing Lights (DB686 HALO) is the device name listed in this FDA 510(k) record. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. It received FDA 510(k) clearance on 2025-04-11 under 510(k) number K243921. The device is classified under product code EBZ. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LED Curing Lights (DB686 HALO)?

LED Curing Lights (DB686 HALO) is a medical device that received FDA 510(k) clearance on 2025-04-11. The listed applicant is Foshan Coxo Medical Instrument Co., Ltd.. The 510(k) number is K243921.

When did LED Curing Lights (DB686 HALO) receive FDA 510(k) clearance?

LED Curing Lights (DB686 HALO) received FDA 510(k) clearance on 2025-04-11, under 510(k) number K243921.

Who is the listed applicant for LED Curing Lights (DB686 HALO)?

The FDA 510(k) record lists Foshan Coxo Medical Instrument Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Curing Lights (DB686 HALO)?

The FDA product code for LED Curing Lights (DB686 HALO) is EBZ.

其他以 Foshan Coxo Medical Instrument Co., Ltd. 為申請人之記錄

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相關器械（代碼：EBZ）

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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