FDA 510(k)

JOVS 電動刺激美容設備（JE2）

K 號：K250227 · 2025-10-17

決定日期2025-10-17

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

JOVS Electric Stimulation Beauty Device (JE2) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Qianyu Technology Co., Ltd.. It received FDA 510(k) clearance on 2025-10-17 under 510(k) number K250227. 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 JOVS Electric Stimulation Beauty Device (JE2)?

JOVS Electric Stimulation Beauty Device (JE2) is a medical device that received FDA 510(k) clearance on 2025-10-17. The listed applicant is Shenzhen Qianyu Technology Co., Ltd.. The 510(k) number is K250227.

When did JOVS Electric Stimulation Beauty Device (JE2) receive FDA 510(k) clearance?

JOVS Electric Stimulation Beauty Device (JE2) received FDA 510(k) clearance on 2025-10-17, under 510(k) number K250227.

Who is the listed applicant for JOVS Electric Stimulation Beauty Device (JE2)?

FDA 510(k) 記錄將深圳千宇科技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 JOVS Electric Stimulation Beauty Device (JE2)?

The FDA product code for JOVS Electric Stimulation Beauty Device (JE2) is NFO.

其他以 Shenzhen Qianyu 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。

K261851LED光療治療面膜（JML1，JML1+JML2）；LED光療治療面膜（JML3，JML3+JML4）；LED光療治療面膜（JML5，JML5+JML7）；LED光療治療面膜（JML6，JML6+JML8）；LED光療治療面膜（JML9，JML9+JML10）K244020皺紋治療設備（JM1，JM2B）K240360皺紋治療設備（JM2）K231800IPL 髮毛去除器，型號：JP1、JR3、JR8、JR9 K220645手持式IPL設備（JOVS 髮毛去除設備）K214113手持式IPL設備（JOVS石墨烯除毛設備）

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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, LLC K260387SYNERJET 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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