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FDA 510(k)

Dermatrix Duo

K-Number: K251836 · 2026-02-06

Decision Date2026-02-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dermatrix Duo is the device name listed in this FDA 510(k) record. The listed applicant is Shenzhen Gsd Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-02-06 under 510(k) number K251836. The device is classified under product code GEI. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Dermatrix Duo?

Dermatrix Duo is a medical device that received FDA 510(k) clearance on 2026-02-06. The listed applicant is Shenzhen Gsd Technology Co., Ltd.. The 510(k) number is K251836.

When did Dermatrix Duo receive FDA 510(k) clearance?

Dermatrix Duo received FDA 510(k) clearance on 2026-02-06, under 510(k) number K251836.

Who is the listed applicant for Dermatrix Duo?

The FDA 510(k) record lists Shenzhen Gsd Technology Co., Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Dermatrix Duo?

The FDA product code for Dermatrix Duo is GEI.

Related Devices (Code: GEI)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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