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

    LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG.

    K Number: K901128 · Decision Jun 5, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    2
    Review Days
    85

    Basic Information

    Device Name
    LASERCOMP MODEL STAR 10 FOR ORAL,GYNECOLOGY SURG.
    K Number
    K901128
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    LASERCOMP
    Date Received
    March 12, 1990
    Decision Date
    June 5, 1990
    Product Code
    GEX
    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
    GEX Powered Laser Surgical Instrument

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    Other Clearances by LASERCOMP

    K Number Device Name
    K901127 LASERCOMP MODEL STAR 10 FOR KNEE ARTHROSCOPY