FDA 510(k)

DeepSkin (DEP100)

K 號：K252621 · 2026-05-08

決定日期2026-05-08

產品代碼NFO

諮詢委員會NE (請提供完整的英文描述，以便進行翻譯。)

決定相當於

器材摘要

DeepSkin (DEP100) is the device name listed in this FDA 510(k) record. The listed applicant is El Global Trade, Ltd.. It received FDA 510(k) clearance on 2026-05-08 under 510(k) number K252621. The device is classified under product code NFO. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the DeepSkin (DEP100)?

DeepSkin (DEP100) is a medical device that received FDA 510(k) clearance on 2026-05-08. The listed applicant is El Global Trade, Ltd.. The 510(k) number is K252621.

When did DeepSkin (DEP100) receive FDA 510(k) clearance?

DeepSkin (DEP100) received FDA 510(k) clearance on 2026-05-08, under 510(k) number K252621.

Who is the listed applicant for DeepSkin (DEP100)?

The FDA 510(k) record lists El Global Trade, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DeepSkin (DEP100)?

The FDA product code for DeepSkin (DEP100) is NFO.

其他以 El Global Trade, Ltd. 為申請人之記錄

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相關器械（代碼：NFO）

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