FDA 510(k)

LED光療面膜（LumiLips FAC07NA）

K 號：K260202 · 2026-03-23

決定日期2026-03-23

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 Masks (LumiLips FAC07NA) is the device name listed in this FDA 510(k) record. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. It received FDA 510(k) clearance on 2026-03-23 under 510(k) number K260202. 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 Masks (LumiLips FAC07NA)?

LED Light Therapy Masks (LumiLips FAC07NA) is a medical device that received FDA 510(k) clearance on 2026-03-23. The listed applicant is Guangdong Newdermo Biotech Co., Ltd.. The 510(k) number is K260202.

When did LED Light Therapy Masks (LumiLips FAC07NA) receive FDA 510(k) clearance?

LED Light Therapy Masks (LumiLips FAC07NA) received FDA 510(k) clearance on 2026-03-23, under 510(k) number K260202.

Who is the listed applicant for LED Light Therapy Masks (LumiLips FAC07NA)?

FDA 510(k) 記錄將廣東新德美生物技術有限公司列為申請人。這並不單獨確立設備製造商的身份。

What is the FDA product code for LED Light Therapy Masks (LumiLips FAC07NA)?

The FDA product code for LED Light Therapy Masks (LumiLips FAC07NA) is OHS.

其他以 Guangdong Newdermo Biotech 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。

K261370LED光療面膜（LED臉部面膜脈搏（FAC06NA））K261052LED光療面膜（LED臉部光療面膜 Pro FAC08NA，LED胸腹部光療面膜 Pro FAC09NA）K260946LED 光療治療面具（K9C-TK, K9C-K, K9P-YK, K9P-K, FM-03BK, FM-09K）K223544LED光療面膜（FM-01、FM-02、FM-03）

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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