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510(k) Data Aggregation

    K Number
    K251836

    Validate with FDA (Live)

    Device Name
    Dermatrix Duo
    Date Cleared
    2026-02-06

    (235 days)

    Product Code
    Regulation Number
    878.4400
    Age Range
    All
    Reference & Predicate Devices
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    N/A

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