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

    SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE

    K Number: K974039 · Decision Jan 12, 1998
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    9
    Review Days
    88

    Basic Information

    Device Name
    SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE
    K Number
    K974039
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    SCHWARTZ ELECTRO-OPTICS, INC.
    Date Received
    October 16, 1997
    Decision Date
    January 12, 1998
    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 SCHWARTZ ELECTRO-OPTICS, INC.

    K Number Device Name
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    K980313 SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940 ERBIUM CRYSTALASE
    K973867 SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 755 LASER SYSTEM
    K973603 SCHWARTZ ELECTRO-OPTICS, INC. CRYSTALASE 1064/532 LASER SYSTEM
    K971404 SCHWARTZ ELECTRO-OPTICS, INC. CLR 2940/ERBIUM CRYSTALASE (FORMERLY TRILASE 2940 ERBIUM LASER
    K953585 SCHWARTZ ELECTRO-OPTICES, INC. TRILASE 2100/20 HOLMIUM LASER
    K954013 TRILASE 2940 ERBIUM LASER
    K952554 SCHWARTZ ELECTRO-OPTICS, INC. TRILASE LASER SYSTEM