FDA 510(k)

LED光療設備（KFB290、KFB291、KFB265、KFB293）

K 號：K241857 · 2024-10-11

申請人Dongguan Boyuan Intelligent Technology Co.,Ltd

決定日期2024-10-11

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

LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) is the device name listed in this FDA 510(k) record. The listed applicant is Dongguan Boyuan Intelligent Technology Co.,Ltd. It received FDA 510(k) clearance on 2024-10-11 under 510(k) number K241857. 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 LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)?

LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) is a medical device that received FDA 510(k) clearance on 2024-10-11. The listed applicant is Dongguan Boyuan Intelligent Technology Co.,Ltd. The 510(k) number is K241857.

When did LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) receive FDA 510(k) clearance?

LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) received FDA 510(k) clearance on 2024-10-11, under 510(k) number K241857.

Who is the listed applicant for LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)?

The FDA 510(k) record lists Dongguan Boyuan Intelligent Technology Co.,Ltd as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293)?

The FDA product code for LED Light Therapy Device (KFB290, KFB291, KFB265, KFB293) is OHS.

其他以 Dongguan Boyuan Intelligent Technology 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。

K250253IPL 髮毛去除器（KCA511/KCA516/KCA522）K250308髮生設備（KCA441-200、KCA441-120、KCA441-88、KCA441-56、KCA441-200S、KCA441-120S、KCA441-88S、KCA441-56S、KCA451-200、KCA451-120、KCA451-88、KCA451-56、KCA451-200S、KCA451-120S、KCA451-88S、KCA451-56S）K240282IPL 髮毛移除設備（型號：KCA450、KCA446、KCA504、KCA505、KCA506、KCA507、KCA508、KCA509、KCA501、KCA423、KCA448、KCA449、KCA502、KCA521）

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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