BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    EPILATOR

    K Number: K952117 · Decision Oct 19, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    24
    Applicant Total
    7
    Review Days
    167

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    EPILATOR
    K Number
    K952117
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    878.5360
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Burke Neutech, Inc.
    Date Received
    May 5, 1995
    Decision Date
    October 19, 1995
    Product Code
    KCX
    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
    KCX Epilator, High Frequency, Tweezer-Type

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (KCX), ordered by most recent decision date.

    DAPELLE HAIR REMOVER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TWEEZER-TYPE EPILATOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    FEMINIQUE SONIC HAIR REMOVER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    SONIQUE HAIR REMOVER

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    FINALLY FREE

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery

    TWEEZER-TYPE EPILATOR

    FDA 510(k)
    FDA Class 1 ·General, Plastic Surgery
    View all

    Other Clearances by Burke Neutech, Inc.

    K Number Device Name
    K955326 SPORTS CONTRAST THERAPY SYSTEM ST 7000
    K943497 CONTRAST 7000 THERAPY SYSTEM
    K945803 THERMAFLEX, MODEL SD 55 C.P.M.H.
    K942926 NEURO-AIDE
    K940160 TS1000 PORTABLE DISPOSABLE COLD THERAPY SYSTEM
    K926151 LSI6000 THERMAL THERAPY SYSTEM