Manufacturer
Shenzhen Gsd Technology Co., Ltd.Dermatrix Duo
Shenzhen Gsd Technology Co., Ltd.
Country / Region:China (CN)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
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—
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Not ingested
EndyMed PRO MAX
K251836 references 2 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K251836 as a predicate
