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FDA 510(k)

DeepSkin (DEP100)

K-Number: K252621 · 2026-05-08

ApplicantEl Global Trade, Ltd.
Decision Date2026-05-08
Product CodeNFO
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

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

Frequently Asked Questions

What is the DeepSkin (DEP100)?

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

When was DeepSkin (DEP100) approved by the FDA?

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

What company makes DeepSkin (DEP100)?

DeepSkin (DEP100) is manufactured by El Global Trade, Ltd..

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

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

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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