Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

Dermatrix Duo

K-Number: K251836 · 2026-02-06

ApplicantShenzhen Gsd Technology Co., Ltd.
Decision Date2026-02-06
Product CodeGEI
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Dermatrix Duo is a medical device manufactured by Shenzhen Gsd Technology Co., Ltd.. It received FDA 510(k) clearance on 2026-02-06 under approval 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. It is manufactured by Shenzhen Gsd Technology Co., Ltd.. The 510(k) number is K251836.

When was Dermatrix Duo approved by the FDA?

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

What company makes Dermatrix Duo?

Dermatrix Duo is manufactured by Shenzhen Gsd Technology Co., Ltd..

What is the FDA product code for Dermatrix Duo?

The FDA product code for Dermatrix Duo is GEI.

Related Devices (Code: GEI)

K161307NICO MyriadNico Corporation K163190InMode RF SystemInmode MD , Ltd. K163373PK AIMGyrus Acmi, Inc. K163106CODMAN Integrated Bipolar Cord and Tubing SetMedos International SARL K162676Voyant Open Fusion DeviceApplied Medical Resources K162941Ligasure Blunt Tip, Sealer/Divider, Nano-coatedCovidien

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.

↑