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

    GYRUS PLASMA SKIN RESURFACING SYSTEM

    K Number: K023111 · Decision Mar 13, 2003
    View on FDA
    Classifications
    1
    FEI Numbers
    839
    Registration Numbers
    839
    Same Product Code
    2251
    Applicant Total
    15
    Review Days
    175

    Basic Information

    Device Name
    GYRUS PLASMA SKIN RESURFACING SYSTEM
    K Number
    K023111
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4400
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    GYRUS MEDICAL, INC.
    Date Received
    September 19, 2002
    Decision Date
    March 13, 2003
    Product Code
    GEI
    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
    GEI Electrosurgical, Cutting & Coagulation & Accessories

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    Other Clearances by GYRUS MEDICAL, INC.

    K Number Device Name
    K050550 GYRUS GENERAL PURPOSE ELECTROSURGICAL GENERATOR
    K050460 GYRUS PLASMACISION AND PLASMABLEND ELECTRODES
    K041999 GYRUS PLASMA SKIN RESURFACING SYSTEM
    K041633 GYRUS PLASMACISION LAPAROSCOPIC SPATULA
    K024286 GYRUS OPEN FORCEPS
    K031085 GYRUS PLASMAKINETIC SUPERPULSE SYSTEM (GENERATOR, ACCESSORIES)
    K031079 EVEREST BIPOLAR NEEDLE ELECTRODE & GYRUS BIPOLAR NEEDLE ELECTRODE
    K031081 EVEREST LP BIPOLAR SCISSORS AND GYRUS LP BIPOLAR SCISSORS
    K031082 EVEREST BIPOLAR L HOOK & PK BIPOLAR L HOOK
    K031080 EVEREST BIPOLAR LYONS DISSECTING FORCEPS & GYRUS BIPOLAR LYONS DISSECTING FORCEPS
    Search all 15 clearances from GYRUS MEDICAL, INC. →