# K251836: Dermatrix Duo

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Gsd Technology Co., Ltd.
- Decided: Feb 6, 2026 after 235 days
- Product code: GEI (Electrosurgical, Cutting & Coagulation & Accessories)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 361 ancestors in all.
No later device cites it as a predicate yet.
0 of 362 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211562: Virtue RF, ShenB Co., Ltd. (2021) Summary page 5.
- K242996: EndyMed PRO MAX, Endymed Medical, Ltd. (2025) Summary page 5.

## Indications for use
The Dermatrix Duo is intended for use in dermatologic procedures for electrocoagulation and hemostasis. The SFR applicator is indicated for: * Relief of minor muscle aches and pain, relief of muscle spasm * Temporary improvement of local blood circulation

Source page: https://510kreport.com/device/K251836
Methodology: https://510kreport.com/methodology