FDA 510(k)

多利再生

K 號：K180875 · 2018-09-14

決定日期2018-09-14

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

POLY REJUV is the device name listed in this FDA 510(k) record. The listed applicant is Medtek Skincare, LLC. It received FDA 510(k) clearance on 2018-09-14 under 510(k) number K180875. 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 POLY REJUV?

POLY REJUV is a medical device that received FDA 510(k) clearance on 2018-09-14. The listed applicant is Medtek Skincare, LLC. The 510(k) number is K180875.

When did POLY REJUV receive FDA 510(k) clearance?

POLY REJUV received FDA 510(k) clearance on 2018-09-14, under 510(k) number K180875.

Who is the listed applicant for POLY REJUV?

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

What is the FDA product code for POLY REJUV?

The FDA product code for POLY REJUV is OHS.

其他以 Medtek Skincare, 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。

K183708多聚澄清

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。