紫外光療法設備
K 號：K250425 · 2025-04-07
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器材摘要
Ultraviolet Phototherapy Device is the device name listed in this FDA 510(k) record. The listed applicant is APK Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-04-07 under 510(k) number K250425. The device is classified under product code FTC. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.
常見問題
What is the Ultraviolet Phototherapy Device?
Ultraviolet Phototherapy Device is a medical device that received FDA 510(k) clearance on 2025-04-07. The listed applicant is APK Technology Co., Ltd.. The 510(k) number is K250425.
When did Ultraviolet Phototherapy Device receive FDA 510(k) clearance?
Ultraviolet Phototherapy Device received FDA 510(k) clearance on 2025-04-07, under 510(k) number K250425.
Who is the listed applicant for Ultraviolet Phototherapy Device?
The FDA 510(k) record lists APK Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Ultraviolet Phototherapy Device?
The FDA product code for Ultraviolet Phototherapy Device is FTC.
相關臨床試驗
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其他以 APK Technology Co., Ltd. 為申請人之記錄
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。
相關器械（代碼：FTC）
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。
K254234光療系統（DUV-COMBO）Choyang Medics Co., Ltd.K253871Klär Lite (RCW-KL1000)Radcliffe Watts, LLCK244022308nm 紫外光光療系統 (UV-K)；308nm 紫外光光療系統 (UV-X)；308nm 紫外光光療系統 (UV-Y)；308nm 紫外光光療系統 (UV-Z)Boston Aesthetics, Inc.K242977308nm Excimer光療設備（CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K）Xuzhou Kernel Medical Equipment Co., Ltd.K242908紫外光療法設備（分組A：SQ308PCHFD、SQ308PCQFD、SQ308PCPFD、SQ308PCNFD、SQ308PCMFD）；紫外光療法設備（分組B：SQ308PHTFF、SQ308PHSFF、SQ308PHRFF、SQ308PHZFG、SQ308PPUFF、SQ308PPVFF、SQ308PPWFG）Shanghai Sigma High-Tech Co., Ltd.K233811DT 控制光療設備Daavlin Distributing Co.
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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