FDA 510(k)

LightStim Elipsa

K 號：K212771 · 2022-01-26

決定日期2022-01-26

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

LightStim Elipsa is the device name listed in this FDA 510(k) record. The listed applicant is Led Intellectual Properties, LLC. It received FDA 510(k) clearance on 2022-01-26 under 510(k) number K212771. 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 LightStim Elipsa?

LightStim Elipsa is a medical device that received FDA 510(k) clearance on 2022-01-26. The listed applicant is Led Intellectual Properties, LLC. The 510(k) number is K212771.

When did LightStim Elipsa receive FDA 510(k) clearance?

LightStim Elipsa received FDA 510(k) clearance on 2022-01-26, under 510(k) number K212771.

Who is the listed applicant for LightStim Elipsa?

FDA 510(k) 記錄將 Led Intellectual Properties, LLC 列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for LightStim Elipsa?

The FDA product code for LightStim Elipsa is OHS.

其他以 Led Intellectual Properties, 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。

K261482LightStim 經皮光療機（1984年）；LightStim 痤瘡光療機（2038年）K153399LightStim Professional LED 床

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

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