BEUDAMED
    FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

    PainFreeze II

    K Number: K232674 · Decision Feb 12, 2024
    View on FDA
    Classifications
    1
    FEI Numbers
    19
    Registration Numbers
    19
    Same Product Code
    22
    Applicant Total
    6
    Review Days
    164

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    Basic Information

    Device Name
    PainFreeze II
    K Number
    K232674
    Device Class
    FDA unclassified
    Clearance Type
    Traditional
    Medical Specialty
    Unknown
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Nuance Medical, LLC
    Date Received
    September 1, 2023
    Decision Date
    February 12, 2024
    Product Code
    MLY
    Advisory Committee
    Unknown
    Review Advisory Committee
    PM
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    MLY Vapocoolant Device

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    Other Clearances by Nuance Medical, LLC

    K Number Device Name
    K210310 CryoDose V 50/50, 175ml Canister Kit, CryoDose V 50/50, 236ml Canister Kit
    K172203 CryoDose TA OTC, Mist Spray, CryoDose TA OTC, Stream Spray
    K162218 Pain Freeze™, Medium Stream Spray, Model #2101; Pain Freeze™, Mist Spray, Model #2102
    K161337 CryoDose H or Similar
    K130995 NUANCE CRYO-FREEZE SPRAY OR CRYO-IN-A-CAN OR VANDOLAY FREEZE SPRAY