BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇨🇦 Canada

    COMMANDER MARK II HAIR REMOVAL SYSTEM

    K Number: K943872 · Decision Oct 26, 1995
    View on FDA
    Classifications
    1
    FEI Numbers
    32
    Registration Numbers
    32
    Same Product Code
    24
    Applicant Total
    1
    Review Days
    444

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    Basic Information

    Device Name
    COMMANDER MARK II HAIR REMOVAL SYSTEM
    K Number
    K943872
    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
    The Helene Edgar Corp.
    Date Received
    August 8, 1994
    Decision Date
    October 26, 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

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