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

    Verruca-Freeze H Plus

    K Number: K252903 · Decision Oct 10, 2025
    View on FDA
    Classifications
    1
    FEI Numbers
    83
    Registration Numbers
    83
    Same Product Code
    261
    Applicant Total
    8
    Review Days
    29

    Basic Information

    Device Name
    Verruca-Freeze H Plus
    K Number
    K252903
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4350
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Cryosurgery, Inc.
    Date Received
    September 11, 2025
    Decision Date
    October 10, 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
    K243487 CryoFreeze Wart and Skin Tag Remover
    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