FDA 510(k)

醫用升罩

K 號：K244048 · 2025-01-16

決定日期2025-01-16

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

Medi Lift Mask is the device name listed in this FDA 510(k) record. The listed applicant is Ya-Man, Ltd.. It received FDA 510(k) clearance on 2025-01-16 under 510(k) number K244048. 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 Medi Lift Mask?

Medi Lift Mask is a medical device that received FDA 510(k) clearance on 2025-01-16. The listed applicant is Ya-Man, Ltd.. The 510(k) number is K244048.

When did Medi Lift Mask receive FDA 510(k) clearance?

Medi Lift Mask received FDA 510(k) clearance on 2025-01-16, under 510(k) number K244048.

Who is the listed applicant for Medi Lift Mask?

The FDA 510(k) record lists Ya-Man, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Medi Lift Mask?

The FDA product code for Medi Lift Mask is NFO.

其他以 Ya-Man, 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。

K250618Medi Lift 基本眼罩醫療設備規範文本 K220198醫用設備規範文本翻譯： Medi Lift PLUS

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。