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

    DELIGHT DENTAL ER: YAG LASER SYSTEM

    K Number: K021616 · Decision Jul 11, 2002
    View on FDA
    Classifications
    1
    FEI Numbers
    476
    Registration Numbers
    479
    Same Product Code
    2793
    Applicant Total
    7
    Review Days
    56

    Basic Information

    Device Name
    DELIGHT DENTAL ER: YAG LASER SYSTEM
    K Number
    K021616
    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
    CONTINUUM ELECTRO-OPTICS, INC.
    Date Received
    May 16, 2002
    Decision Date
    July 11, 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 CONTINUUM ELECTRO-OPTICS, INC.

    K Number Device Name
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    K014234 MEDLITE IV Q-SWITCHEDND: YAGLASER REPLACED BY THE MEDLITE C6 Q-SWICTHED ND: YAG LASER
    K011677 MEDLITE Q-SWITCHED ND:YAG LASER REPLACED BY THE MEDLITE C3 Q-SWTICHED ND:YAG LASER
    K933057 MULTILITE ERBIUM:YAG SURGICAL LASER SYSTEM