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510(k) Data Aggregation

    K Number
    DEN230011
    Device Name
    OcuCool
    Date Cleared
    2024-09-30

    (592 days)

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

    RecensMedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    OcuCool is a cooling anesthesia device intended for topical application to the conjunctiva and sclera. OcuCool is intended for the temporary reduction of pain associated with intravitreal injections. OcuCool is indicated for patients who are allergic to deep penetrating pharmaceutical based anesthetics used for temporarily reducing pain during and following intravitreal injections.
    Device Description
    The OcuCool is a hand-held, cooling anesthesia device that provides rapid and controlled cooling to the conjunctiva and sclera. It is intended to provide an anesthetic effect via a controlled cooling treatment. The main device performs controlled thermoelectric cooling of a single-use sterile OcuCool Tip. The hand-held device has a rechargeable battery, an LCD display screen to show device status, and two LED indicators to show cooling status and battery charging status. Other features of the hand-held device include the Priming Button, which activates the cooling process in preparation for device use and the Cooling Trigger, which activates the cooling anesthesia process. The device has a built-in 30 second timer and alarm to indicate the effective duration of the anesthetic effect after device use.
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    K Number
    K230599
    Device Name
    TargetCool™
    Date Cleared
    2023-06-22

    (111 days)

    Product Code
    Regulation Number
    878.4350
    Why did this record match?
    Applicant Name (Manufacturer) :

    RecensMedical, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    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 the device status through the LCD display. Also, if the measured temperature is below -1 ℃ and lasts for more than 1 second, the status light blinks in blue with a beep sound. The principle of pain relief through skin cooling is as the skin cools by spraying the cryogen onto the skin, the nerve conduction velocity (NCV) of the skin decreases, increasing the pain threshold (PTH) and pain tolerance (PT). Through this mechanism, pain in the skin is relieved. The advances represented by TargetCool™ lie in the fact that the device executes this process in a precise, controlled, and rapid way.
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