FDA 510(k)

Dermatrix Duo

Número K: K251836 · 2026-02-06

RequerenteShenzhen Gsd Technology Co., Ltd.

Data da decisão2026-02-06

Código do produtoGEI

Comité consultivoSU

DecisãoSubstantially Equivalent

Resumo do dispositivo

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.

Perguntas frequentes

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.

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