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FDA 510(k)

LED 面部護膚罩（MJ-66DB、MK-99、MK-99A、MK-99M、MJ-66C）

K 號：K260150 · 2026-04-22

申請人NOOANCE
決定日期2026-04-22
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 FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) is the device name listed in this FDA 510(k) record. The listed applicant is NOOANCE. It received FDA 510(k) clearance on 2026-04-22 under 510(k) number K260150. 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 FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) is a medical device that received FDA 510(k) clearance on 2026-04-22. The listed applicant is NOOANCE. The 510(k) number is K260150.

When did LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) receive FDA 510(k) clearance?

LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) received FDA 510(k) clearance on 2026-04-22, under 510(k) number K260150.

Who is the listed applicant for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

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

What is the FDA product code for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C)?

The FDA product code for LED FACIAL MASK (MJ-66DB, MK-99, MK-99A, MK-99M, MJ-66C) is OHS.

相關臨床試驗

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。

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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 LimitedK261482LightStim 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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