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FDA 510(k)

LED光療機（G1、G3、G4、G6）

K 號：K242638 · 2024-11-27

申請人Shenzhen Walton Technology Co., Ltd.
決定日期2024-11-27
產品代碼OHS
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

LED Light Therapy Machine (G1, G3, G4, G6) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Walton Technology Co., Ltd.. It received FDA 510(k) clearance on 2024-11-27 under 510(k) number K242638. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the LED Light Therapy Machine (G1, G3, G4, G6)?

LED Light Therapy Machine (G1, G3, G4, G6) is a medical device that received FDA 510(k) clearance on 2024-11-27. The listed applicant is Shenzhen Walton Technology Co., Ltd.. The 510(k) number is K242638.

When did LED Light Therapy Machine (G1, G3, G4, G6) receive FDA 510(k) clearance?

LED Light Therapy Machine (G1, G3, G4, G6) received FDA 510(k) clearance on 2024-11-27, under 510(k) number K242638.

Who is the listed applicant for LED Light Therapy Machine (G1, G3, G4, G6)?

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

What is the FDA product code for LED Light Therapy Machine (G1, G3, G4, G6)?

The FDA product code for LED Light Therapy Machine (G1, G3, G4, G6) is OHS.

相關臨床試驗

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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相關器械（代碼：OHS）

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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