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

    LASER FLARE CELL METER FC-1000

    K Number: K880920 · Decision Sep 27, 1988
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    10
    Review Days
    207

    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
    LASER FLARE CELL METER FC-1000
    K Number
    K880920
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Applicant
    Kowa Optimed, Inc.
    Date Received
    March 4, 1988
    Decision Date
    September 27, 1988
    Product Code
    HJO
    Advisory Committee
    Ophthalmic
    Review Advisory Committee
    OP
    Third Party
    N

    Classifications

    This FDA 510(k) entry is associated with 1 FDA classification via its product code.

    Product Code Device Name
    HJO Biomicroscope, Slit-Lamp, Ac-Powered

    Similar 510(k) Clearances

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

    VISUREF 600

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    HP-OCT (HP-OCT)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Kowa SL-19

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MiiS Horus Eye Anterior Camera

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    Sunkingdom Slit Lamp

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    IOLMaster 700

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
    View all

    Other Clearances by Kowa Optimed, Inc.

    K Number Device Name
    K013805 KOWA AUTOMATED TONOMETER KT-500
    K961090 AUTOMATIC VISUAL FIELD PLOTTER AP-125
    K960924 KOWA HAND-HELD APPLANATION TONOMETER HA-1
    K955442 KOWA SC-1200 PHOTO SLIT LAMP SYSTEM
    K954781 KOWA GENESIS HAND-HELD FUNDUS CAMERA
    K954780 KOWA PROFESSIONAL FUNDUS CAMERA MODELS FX-500, FX-500S, FX-500C
    K954782 KOWA PORTABLE SLIT LAMP SL-14 & SL-14B
    K913852 LASER FLARE METER
    K881219 AUTOMATIC PERIMETER, AP-340