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FDA 510(k)

308nm 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)

K 號：K244022 · 2025-03-13

申請人Boston Aesthetics, Inc.
決定日期2025-03-13
產品代碼FTC
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

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) is the device name listed in this FDA 510(k) record. The listed applicant is Boston Aesthetics, Inc.. It received FDA 510(k) clearance on 2025-03-13 under 510(k) number K244022. 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 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)?

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) is a medical device that received FDA 510(k) clearance on 2025-03-13. The listed applicant is Boston Aesthetics, Inc.. The 510(k) number is K244022.

When did 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) receive FDA 510(k) clearance?

308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) received FDA 510(k) clearance on 2025-03-13, under 510(k) number K244022.

Who is the listed applicant for 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)?

The FDA 510(k) record lists Boston Aesthetics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z)?

The FDA product code for 308nm UV Phototherapy System (UV-K); 308nm UV Phototherapy System (UV-X); 308nm UV Phototherapy System (UV-Y); 308nm UV Phototherapy System (UV-Z) is FTC.

相關臨床試驗

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NCT07608549FLASH 預試階段 1 安全性研究NOT_YET_RECRUITINGNCT06562205PAP系統外部臨床研究（ECS）NOT_YET_RECRUITINGNCT06443177對於動脈瘤性硬腦膜下出血引起的腦血管收縮，交感調節的影響SUSPENDEDNCT07095751人工智能協助的Uro-Cam導尿管評估系統，用於診斷膀胱癌NOT_YET_RECRUITING

其他以 Boston Aesthetics, Inc. 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。

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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, LLCK250425紫外光療法設備APK Technology Co., Ltd.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

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