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510(k) Data Aggregation

    K Number
    K253114
    Device Name
    TargetCool™ (RM-DT02W)
    Manufacturer
    RecensMedical Inc.
    Date Cleared
    2025-10-16

    (22 days)

    Product Code
    GEH
    Regulation Number
    878.4350
    Type
    Special
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K230599
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    TargetCool™ (Cooling mode / Boosting mode) is indicated for the temporary reduction of pain, swelling, inflammation, and hematoma from minor surgical procedures, minor sprains or other minor sports injuries, and as an adjunct to rehabilitative treatment (e.g., intermittent cold with stretch).

    TargetCool™ (Freezing mode) is indicated for the surgical destruction of target tissue by applying cryogenic gases at extreme low temperatures

    • Molluscum Contagiosum
    • Skin Tags
    • Actinic Keratosis
    • Lentigo
    • Verruca Plana
    • Verruca Vulgaris
    • Verruca Lesions
    • Genital Lesions
    • Seborrheic Keratosis
    Device Description

    TargetCool™ is a handheld device that can deliver rapid, precise, and controlled cooling to the skin tissue. The TargetCool™ device consists of a main device, nozzle, a guard, a filter, and a cartridge.

    The main device produces controlled cooling based on thermoelectric cooling, which controls the temperature of the targeted area. TargetCool™ displays the skin temperature measured in real time, the set cooling temperature and time, and the device status through the LCD display. Also, if the measured temperature is below -1°C and lasts for more than 1 second, the status light blinks in blue with a beep sound.

    AI/ML Overview

    N/A

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