LED治療燈（COB1400，HP1800PRO）
K 號：K253874 · 2026-03-03
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器材摘要
LED Therapy Light (COB1400, HP1800PRO) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Hanhua Opto Co., Ltd.. It received FDA 510(k) clearance on 2026-03-03 under 510(k) number K253874. 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 Therapy Light (COB1400, HP1800PRO)?
LED Therapy Light (COB1400, HP1800PRO) is a medical device that received FDA 510(k) clearance on 2026-03-03. The listed applicant is Shenzhen Hanhua Opto Co., Ltd.. The 510(k) number is K253874.
When did LED Therapy Light (COB1400, HP1800PRO) receive FDA 510(k) clearance?
LED Therapy Light (COB1400, HP1800PRO) received FDA 510(k) clearance on 2026-03-03, under 510(k) number K253874.
Who is the listed applicant for LED Therapy Light (COB1400, HP1800PRO)?
The FDA 510(k) record lists Shenzhen Hanhua Opto Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for LED Therapy Light (COB1400, HP1800PRO)?
The FDA product code for LED Therapy Light (COB1400, HP1800PRO) is OHS.
相關臨床試驗
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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
在 FDA 資料庫中查看 →資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。
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