BEUDAMED
    FDA 510(k) FDA class 2 Substantially Equivalent 🇮🇱 Israel

    OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND

    K Number: K014100 · Decision Jan 8, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    5
    Review Days
    26

    Basic Information

    Device Name
    OPUS SPECTRUM (A MODEL OF OPUS 20), MODEL 2ND
    K Number
    K014100
    Device Class
    FDA class 2
    Clearance Type
    Special
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    OPUSDENT LTD.
    Date Received
    December 13, 2001
    Decision Date
    January 8, 2002
    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 OPUSDENT LTD.

    K Number Device Name
    K021508 OPUSDUO EC DENTAL LASER SYSTEM
    K011769 OPUS 10 (WITH TOOTH WHITENING APPLICATION), MODEL 2ND
    K002899 OPUS 20, MODEL 1ST
    K000990 OPUS 10 DENTAL DIODE LASER