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FDA 510(k)

臉部與身體美妝設備（INIA-BD001、INIA-BD002、INIA-BD003、INIA-BD004、F2C15、F3222 Pro、F5516、F3606、F2210 Pro、F5808、INIA-ED001、INIA-ED002、INIA-BLD001、E1507）

K 號：K252553 · 2025-10-09

申請人Shenzhen Jianchao Intelligent Technology Co., Ltd.
決定日期2025-10-09
產品代碼NFO
諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)
決定相當於

器材摘要

Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Jianchao Intelligent Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-09 under 510(k) number K252553. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)?

Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) is a medical device that received FDA 510(k) clearance on 2025-10-09. The listed applicant is Shenzhen Jianchao Intelligent Technology Co., Ltd.. The 510(k) number is K252553.

When did Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) receive FDA 510(k) clearance?

Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) received FDA 510(k) clearance on 2025-10-09, under 510(k) number K252553.

Who is the listed applicant for Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)?

FDA 510(k) 記錄將深圳健超智能技術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 Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)?

The FDA product code for Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507) is NFO.

相關臨床試驗

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。

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 Shenzhen Jianchao Intelligent 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。

K261705除毛設備（R3C16-G Pro, R3C16-V Pro）K253833臉部與身體美妝設備（型號：INIA-BD001、INIA-BD002、INIA-BD003、INIA-BD004、F2C15、F3222 Pro、F5516、F3606、F2210 Pro、F5808、INIA-ED001、INIA-ED002、INIA-BLD001、E1507）K242710除毛設備（R3C16-P、R3C16-W、R3C16-G、R3C16-P Pro、R3C16-W Pro、R3C16-G Pro、R3505-W、R3505-B、R3505-W Pro、R3505-B Pro）K232575除毛設備，型號：R2815-G Pro，R2815-G

相關器械（代碼：NFO）

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。

K261370LED光療面膜（LED臉部面膜脈搏（FAC06NA））Guangdong Newdermo Biotech Co., Ltd.K262861PureLift Pro MaxXtreem Pulse, LLCK260387SYNERJET PRO (SP-1003)；InPhiuse (SP-1003)；WOWJET (SP-1003)Hironic Co., Ltd.K253932FACEGYM Pro 裝置 (HD-109)Shenzhen Kaiyan Medical Equipment Co., Ltd.K260179VITA多功能頭刷（TB-2343F，TB-2442F）Touchbeauty Beauty & Health (Shenzhen) Co., Ltd.K260895Ulike 清晰零 (YC10 BU)Guangxi Ulike Medical Technology Co., Ltd.

官方來源

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