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FDA 510(k)

Bestqool LED治療設備（LMK-001、LMK-004、LMK-005、LMK-006）

K 號：K242789 · 2025-01-02

申請人Dongguan Laiguang Electronic Technology Co., Ltd.
決定日期2025-01-02
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

Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Laiguang Electronic Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-01-02 under 510(k) number K242789. 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 Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)?

Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) is a medical device that received FDA 510(k) clearance on 2025-01-02. The listed applicant is Dongguan Laiguang Electronic Technology Co., Ltd.. The 510(k) number is K242789.

When did Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) receive FDA 510(k) clearance?

Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) received FDA 510(k) clearance on 2025-01-02, under 510(k) number K242789.

Who is the listed applicant for Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)?

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

What is the FDA product code for Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006)?

The FDA product code for Bestqool LED Therapy Device (LMK-001,LMK-004,LMK-005,LMK-006) 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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