FDA 510(k)

308nm 激光系統

K 號：K200971 · 2020-12-15

申請人Xuzhou Kernel Medical Equipment Co., Ltd.

決定日期2020-12-15

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 Excimer System is the device name listed in this FDA 510(k) record. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. It received FDA 510(k) clearance on 2020-12-15 under 510(k) number K200971. 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 Excimer System?

308nm Excimer System is a medical device that received FDA 510(k) clearance on 2020-12-15. The listed applicant is Xuzhou Kernel Medical Equipment Co., Ltd.. The 510(k) number is K200971.

When did 308nm Excimer System receive FDA 510(k) clearance?

308nm Excimer System received FDA 510(k) clearance on 2020-12-15, under 510(k) number K200971.

Who is the listed applicant for 308nm Excimer System?

FDA 510(k) 記錄將徐州核子醫療設備有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for 308nm Excimer System?

The FDA product code for 308nm Excimer System is FTC.

其他以 Xuzhou Kernel Medical Equipment 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。

K261775紫外光療法（KN-4001A、KN-4001B、KN-4001AB）K242977308nm Excimer光療設備（CN-308E, KN-4003B3, KN-4003B4, KN-5000C KN-5000D, KN-5000H, KN-5000K）K222751LED光療設備，KN-7000L K200929髮生系統 K190685髮生系統 K181805紫外光療法

查看所有 8 項裝置 →

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, LLC K250425紫外光療法設備APK Technology Co., Ltd.K244022308nm 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.

官方來源

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