FDA 510(k)

皺紋退避者Pro光療臉部面膜（型號：PH-m03）

K 號：K252983 · 2025-12-17

申請人Shenzhen Goodwind Technology Development Co., Ltd.

決定日期2025-12-17

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

Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Goodwind Technology Development Co., Ltd.. It received FDA 510(k) clearance on 2025-12-17 under 510(k) number K252983. 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 Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)?

Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) is a medical device that received FDA 510(k) clearance on 2025-12-17. The listed applicant is Shenzhen Goodwind Technology Development Co., Ltd.. The 510(k) number is K252983.

When did Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) receive FDA 510(k) clearance?

Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) received FDA 510(k) clearance on 2025-12-17, under 510(k) number K252983.

Who is the listed applicant for Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)?

FDA 510(k) 記錄將深圳好風科技開發有限公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03)?

The FDA product code for Wrinkle Retreat Pro Light Therapy Face Mask (Model: PH-m03) is OHS.

其他以 Shenzhen Goodwind Technology Development 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。

K261602眼復原專家 (PH-e03)K222316IPL 髮毛去除器

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。