FDA 510(k)

光療頸部護膚罩（1019135）

K 號：K252096 · 2025-10-01

決定日期2025-10-01

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

Light Therapy Decollete Mask (1019135) is the device name listed in this FDA 510(k) record. The listed applicant is Merchsource, LLC. It received FDA 510(k) clearance on 2025-10-01 under 510(k) number K252096. 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 Light Therapy Decollete Mask (1019135)?

Light Therapy Decollete Mask (1019135) is a medical device that received FDA 510(k) clearance on 2025-10-01. The listed applicant is Merchsource, LLC. The 510(k) number is K252096.

When did Light Therapy Decollete Mask (1019135) receive FDA 510(k) clearance?

Light Therapy Decollete Mask (1019135) received FDA 510(k) clearance on 2025-10-01, under 510(k) number K252096.

Who is the listed applicant for Light Therapy Decollete Mask (1019135)?

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

What is the FDA product code for Light Therapy Decollete Mask (1019135)?

The FDA product code for Light Therapy Decollete Mask (1019135) is OHS.

其他以 Merchsource, 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。

K251531空氣壓縮靴 1018195,1018196 K252093光療面膜（1019055）

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。

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官方來源

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