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

    CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE

    K Number: K112880 · Decision Jan 31, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    13
    Registration Numbers
    14
    Same Product Code
    21
    Applicant Total
    1
    Review Days
    489

    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
    CLEARPATH DS-120(R) LENS FLUORESCENCE BIOMICROSCOPE
    K Number
    K112880
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.1570
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Freedom Meditech, Inc.
    Date Received
    September 30, 2011
    Decision Date
    January 31, 2013
    Product Code
    MYC
    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
    MYC Ophthalmoscope, Laser, Scanning

    Similar 510(k) Clearances

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

    OcuMet Beacon (OCUB100)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    MAIA (AHMACME001)

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DRSplus

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EIDON FA, EIDON, EIDON AF, EIDON UWFL

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    DRSplus

    FDA 510(k)
    FDA Class 2 ·Ophthalmic

    EIDON FA

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