BEUDAMED
    FDA 510(k) FDA class 1 Substantially Equivalent 🇺🇸 United States

    MYVISIONTRACK(TM)

    K Number: K121738 · Decision Feb 22, 2013
    View on FDA
    Classifications
    1
    FEI Numbers
    9
    Registration Numbers
    9
    Same Product Code
    7
    Applicant Total
    2
    Review Days
    254

    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
    MYVISIONTRACK(TM)
    K Number
    K121738
    Device Class
    FDA class 1
    Clearance Type
    Traditional
    Regulation Number
    886.1330
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Vital Art and Science Incorporated
    Date Received
    June 13, 2012
    Decision Date
    February 22, 2013
    Product Code
    HOQ
    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
    HOQ Grid, Amsler

    Similar 510(k) Clearances

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

    Alleye

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    myVision Track Model 005

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MASCULAR COMPUTERIZED PSYCHOPHYSICAL TEST (MCPT)

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    KREDA DISC

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MODIFIED DEVICE FOR SELF EXAMINATION OF EYES

    FDA 510(k)
    FDA Class 1 ·Ophthalmic

    MACULAR FUNCTION ANALYZER

    FDA 510(k)
    FDA Class 1 ·Ophthalmic
    View all

    Other Clearances by Vital Art and Science Incorporated

    K Number Device Name
    K143211 myVision Track Model 005