BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇺🇸 United States

    CryoFreeze Wart and Skin Tag Remover

    K Number: K243487 · Decision Mar 13, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    8
    Review Days
    125

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    Basic Information

    Device Name
    CryoFreeze Wart and Skin Tag Remover
    K Number
    K243487
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cryosurgery, Inc.
    Date Received
    November 8, 2024
    Decision Date
    March 13, 2025
    Product Code
    GEH
    Advisory Committee
    General, Plastic Surgery
    Review Advisory Committee
    SU
    Third Party
    N

    Classifications

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

    Product Code Device Name
    GEH Unit, Cryosurgical, Accessories

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    Other Clearances by Cryosurgery, Inc.

    K Number Device Name
    K253000 CryoFreeze Wart and Skin Tag Remover
    K252903 Verruca-Freeze H Plus
    K243454 Verruca-Freeze H
    K233347 Verruca-Freeze® H
    K982506 VERRUCA-FREEZE CRYOSURGERY DELIVERY SYSTEM
    K955083 VERRUCA-FREEZE CRYOSURGICAL DELIVERY SYSTEM (MODIFICATION)
    K944221 VERRUCA-FREEZE(TM) CRYOSURGICAL DELIVERY SYST, MODIFIED