FDA 510(k)

星形形成器

K 號：K234061 · 2024-07-01

決定日期2024-07-01

產品代碼KPI

諮詢委員會GU

決定相當於

器材摘要

StarFormer is the device name listed in this FDA 510(k) record. The listed applicant is Fotona D.O.O.. It received FDA 510(k) clearance on 2024-07-01 under 510(k) number K234061. The device is classified under product code KPI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the StarFormer?

StarFormer is a medical device that received FDA 510(k) clearance on 2024-07-01. The listed applicant is Fotona D.O.O.. The 510(k) number is K234061.

When did StarFormer receive FDA 510(k) clearance?

StarFormer received FDA 510(k) clearance on 2024-07-01, under 510(k) number K234061.

Who is the listed applicant for StarFormer?

FDA 510(k) 記錄將 Fotona D.O.O. 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for StarFormer?

The FDA product code for StarFormer is KPI.

其他以 Fotona D.O.O. 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。

K252723Dynamis Pro 系列 K241785StarFormer (M008-3T)K242202LightWalker 激光系統家族 K221274StarFormer, 紧波 K223540AvalancheLase Family K221712Fotona XPulse 激光系統家族（XPulse 1064 nm、XPulse 810 nm、XPulse 980 nm）

查看所有 17 項裝置 →

相關器械（代碼：KPI）

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。

K262353BTL-299-FBTL Industries, Inc.K260178骨盆肌肉訓練器（KM510、KM516B）Shenzhen Konmed Technology Co., Ltd.K252601骨盆肌肉訓練器（PC22A）；骨盆肌肉訓練器（PC22A-L）；骨盆肌肉訓練器（PC22E）；骨盆肌肉訓練器（PC22E-L）Hunan Accurate Bio-Medical Technology Co., Ltd.K252552骨盆底復健治療設備（PD2301/PD2302/PD2303）Shenzhen Changkun Technology Co., Ltd.K252831骨盆底治療裝置 (DLR-8920, DLR-8921, DLR-8922, DLR-8923, DLR-8924, DLR-8925, DLR-8926, DLR-8927)Dolanvy (Suzhou) Medical Technology Co., Ltd.K252334PELVIPOWER 盆腔功能磁刺激器（PELVIPOWER 盆腔FMS）（033-0-1100-02）Pontemedag

官方來源

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