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Dermatrix Duo

Shenzhen Gsd Technology Co., Ltd.

Country / Region:China (CN)Submission type:Traditional

Product code GEI· 21 CFR 878.4400

Summary PDF

Product code

GEI
21 CFR 878.4400

Predicate devices

2

Cited as predicate

0

Device details

FDA 510(k) registration fields

K number
K251836
Device name
Dermatrix Duo
Country / Region
China(CN)
Product code
GEI
Device class
Class 2
Regulation number
21 CFR 878.4400
Date received
2025-06-16
Decision date
2026-02-06
Submission type
Traditional
Technology type
RF Ablation(AI inferred)
Clinical applications
Pain ManagementOther
Primary application
Pain Management
Classification source
AI classified

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

Intended 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

Device Description

The Dermatrix Duo system includes the system main body, a footswitch and two handpieces, the Microneedle RF (MFR) and the Superficial RF (SFR). The MFR handpiece is a microneedling handpiece that has 2 different configurations of cartridges: a 16 needle and a 49 needle. The SFR handpiece has 1 configuration consisting of 64 non-invasive tips. The control panel is equipped with an LCD touch screen so that users may easily adjust parameters for optimal settings. The software provides device and clinical information to the users. The MFR handpiece creates heat within the target dermal tissue via micro needles inserted into the tissue. The microneedle cartridges are sterilized using ethylene oxide. Using the SFR handpiece, the Dermatrix Duo system creates heat within the target dermal tissue via a matrix of electrodes on the SFR tip. There is only one type of handpiece tip (8x8 RF electrodes) that is non-sterile. RF energy is delivered to the target tissue using the handpiece, the tip of the handpiece being placed in light contact with the epidermis, and the handpiece being held at right angles to the target tissue. As the RF energy passes through the skin, it generates an electrothermal reaction which is capable of achieving controlled coagulation of the target tissue.

Summary parsed at:2026-06-19 06:01:33 UTC

Predicate devices

2

K251836 references 2 predicate/reference devices

Cited as predicate

0

No later 510(k)s cite this device yet

Other submissions will appear here when they list K251836 as a predicate