FDA 510(k)

光療面膜（1019055）

K 號：K252093 · 2025-10-16

決定日期2025-10-16

產品代碼OHS

諮詢委員會SU 請提供完整的描述文本，以便我進行翻譯。

決定相當於

器材摘要

Light Therapy Mask (1019055) is the device name listed in this FDA 510(k) record. The listed applicant is Merchsource, LLC. It received FDA 510(k) clearance on 2025-10-16 under 510(k) number K252093. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Light Therapy Mask (1019055)?

Light Therapy Mask (1019055) is a medical device that received FDA 510(k) clearance on 2025-10-16. The listed applicant is Merchsource, LLC. The 510(k) number is K252093.

When did Light Therapy Mask (1019055) receive FDA 510(k) clearance?

Light Therapy Mask (1019055) received FDA 510(k) clearance on 2025-10-16, under 510(k) number K252093.

Who is the listed applicant for Light Therapy Mask (1019055)?

The FDA 510(k) record lists Merchsource, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Light Therapy Mask (1019055)?

The FDA product code for Light Therapy Mask (1019055) is OHS.

其他以 Merchsource, LLC 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。

K251531空氣壓縮靴 1018195,1018196 K252096光療頸部護膚罩（1019135）

相關器械（代碼：OHS）

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。

K260767臉部美顏設備（臉部面膜LED美顏設備 A-901；臉部LED & EMS美顏設備 A-902；臉部面膜LED & EMS美顏設備 A-907）Kam Yuen Plastic Products , Ltd.K261602眼復原專家 (PH-e03)Shenzhen Goodwind Technology Development Co., Ltd.K261601LED光療面膜（M01、M02、M03、M05、M06、M07、M08）Shenzhen Chuangtong Yigou Technology Co., Ltd.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）Shenzhen Qianyu Technology Co., Ltd.K261496LED光療面膜（PE748、PE749、PE756）Duplex International Trading Limited K261482LightStim 經皮光療機（1984年）；LightStim 痤瘡光療機（2038年）Led Intellectual Properties, LLC

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。