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510(k) Data Aggregation

    K Number
    K233118
    Device Name
    DUET-V (Model: ESK-3261DV)
    Date Cleared
    2025-01-03

    (464 days)

    Product Code
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Eunsung Global Corp.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The radiofrequency energy delivery components of the DUET-V(ESK-3261DV) and Accessories are indicated for use in: - Fractional Tips (FRF Tips): Fractional Tip is intended for use in dermatological procedures requiring ablation and resurfacing of the skin. - Thermal Tips (TRF Tips): Dermatologic and general surgical procedures for electrocoagulation
    Device Description
    DUET-V (Model: ESK-3261DV) is a High Frequency Therapy Device system using 4 MHz high frequency electrical current. Single-use, disposable Treatment Tips attach to the handpiece that comes into contact with the patient during treatment procedures. Treatment tips are classified as direct skin contact devices of limited duration (<24 hours). The RF handpiece has 2 types of fractional tips and 3 types of thermal tips. The tips are disposable and are provided in a non-sterile state. Mono-polar electrodes TRF TIP-S, TRF TIP-R, and TRF TIP-E are used with a grounding pad. Bipolar electrodes FRF TIP-64 and FRF TIP-100, unlike mono-polar electrodes, do not have a ground pad and current flows between electrodes on the contact surface. The tip has three modes: Shot mode, Auto Shot mode, and Continuous mode - Shot Mode this mode delivers the output value set by the user once - Auto Shot Mode In this mode, the set output value delivered continuously according . to the interval time set by the user. (only TRF-TIP-S) - Continuous Mode - this mode continuously delivers RF current until stopped by the user.
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