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

    NIIC LASER SYSTEM

    K Number: K896988 · Decision Jan 23, 1990
    View on FDA
    Classifications
    1
    FEI Numbers
    478
    Registration Numbers
    480
    Same Product Code
    2867
    Applicant Total
    16
    Review Days
    49

    Research this 510(k) in seconds

    The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.

    Free to try · every answer cites its records

    Ask the Research Assistant See examples

    Basic Information

    Device Name
    NIIC LASER SYSTEM
    K Number
    K896988
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    878.4810
    Medical Specialty
    General, Plastic Surgery
    Decision
    Substantially Equivalent
    Applicant
    Niic U.S.A., Inc.
    Date Received
    December 5, 1989
    Decision Date
    January 23, 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

    Similar 510(k) Clearances

    Other 510(k) clearances with the same product code (GEX), ordered by most recent decision date.

    Hemolase Fiber (Hemo-R-0.40-2.5/Hemo-R-0.60-2.5/Hemo-R-0.40-1.8/Hemo-R-0.60-1.8)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    PICOSURE WORKSTATION

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LumiGlam Laser System (SHE-LSP601-3)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LASEmaR 1500

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    LUNE PureHygiene

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery

    Boston 2910 (Boston 2910)

    FDA 510(k)
    FDA Class 2 ·General, Plastic Surgery
    View all

    Other Clearances by Niic U.S.A., Inc.

    K Number Device Name
    K902133 MODEL IS102S ND:YAG SURGICAL LASER SYSTEM
    K901205 MODELS IR103,IR107,IR104,IR205 (ADD'L APPLICATION)
    K902063 NIIC MODEL 15 CARBON-DIOXIDE SURGICAL LASER SYSTEM
    K901204 EXPANDED MARKETING OF MODELS IR104 & IR205 LASERS
    K900185 NIIC MODEL: DX901 ASPIRATION SYSTEM
    K895581 MODEL: IR205 ARTICULATED SURGICAL LASER
    K895247 MODEL IR103 SURGICAL LASER SYSTEM
    K892359 MODEL NUMBER: IR204 CO2 SURGICAL LASER SYSTEM
    K895239 MODEL IR107 50-WATT CARBON-DIOXIDE SURGICAL LASER
    K894074 CO2 SURGICAL LASER SYSTEM
    Search all 16 clearances from Niic U.S.A., Inc. →