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

    LED LAMP OR OTHER

    K Number: K092883 · Decision Dec 18, 2009
    View on FDA
    Classifications
    1
    FEI Numbers
    54
    Registration Numbers
    55
    Same Product Code
    107
    Applicant Total
    1
    Review Days
    91

    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
    LED LAMP OR OTHER
    K Number
    K092883
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1850
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Statement
    Applicant
    Intravista Medical Systems, Inc.
    Date Received
    September 18, 2009
    Decision Date
    December 18, 2009
    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