FDA 510(k)

MF SC GEN2 面部雕塑系統

K 號：K252218 · 2025-07-18

決定日期2025-07-18

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

MF SC GEN2 Facial Toning System is the device name listed in this FDA 510(k) record. The listed applicant is Micro Current Technology, Inc.. It received FDA 510(k) clearance on 2025-07-18 under 510(k) number K252218. 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 MF SC GEN2 Facial Toning System?

MF SC GEN2 Facial Toning System is a medical device that received FDA 510(k) clearance on 2025-07-18. The listed applicant is Micro Current Technology, Inc.. The 510(k) number is K252218.

When did MF SC GEN2 Facial Toning System receive FDA 510(k) clearance?

MF SC GEN2 Facial Toning System received FDA 510(k) clearance on 2025-07-18, under 510(k) number K252218.

Who is the listed applicant for MF SC GEN2 Facial Toning System?

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

What is the FDA product code for MF SC GEN2 Facial Toning System?

The FDA product code for MF SC GEN2 Facial Toning System is NFO.

其他以 Micro Current Technology, 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。

K233095S21 非處方外用經皮電神經刺激器 K233525MF SC 面部緊致系統 K183189超級OTC臉部緊緻系統 K181062超臉部緊緻系統

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

在 FDA 資料庫中查看 →

資料來源為 FDA Open API。如需最新且權威的資訊，請始終參閱官方記錄。