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510(k) Data Aggregation

    K Number
    K250217
    Device Name
    AGNES Ultra
    Manufacturer
    Agnes Medical Co., Ltd
    Date Cleared
    2025-09-03

    (222 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K233120,K242469
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    AGNES RF (DL) handpiece, AGNES RF (F) handpiece and AGNES RF (B) handpiece of AGNES Ultra are intended for use in dermatologic and general surgical procedures for electrocoagulation and hemostasis.

    Device Description

    AGNES Ultra is used to coagulate the patient's tissue. AGNES Ultra is a medical device combined with RF current, to function as an electrosurgical device for use in dermatology and general surgical procedures. It is possible to select and change modes, parameters, outputs, etc. using the panel on the main body. It consists of the main device, LCD screen, handpieces, single use electrodes, Neutral electrode pad, NE pad cable, food switch.

    RF energy handpiece is AGNES RF (DL) handpieces, AGNES RF (F) handpiece and AGNES RF (B) handpiece.
    that delivers RF energy through the disposable electrode in the handpiece.

    AI/ML Overview

    N/A

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