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

    FSYX Ocular Pressure Adjusting Pump

    K Number: K252455 · Decision Apr 30, 2026
    View on FDA
    Classifications
    1
    FEI Numbers
    1
    Registration Numbers
    1
    Same Product Code
    1
    Applicant Total
    2
    Review Days
    268

    Basic Information

    Device Name
    FSYX Ocular Pressure Adjusting Pump
    K Number
    K252455
    Device Class
    FDA class 2
    Clearance Type
    Traditional
    Regulation Number
    886.5000
    Medical Specialty
    Ophthalmic
    Decision
    Substantially Equivalent
    Statement or Summary
    Summary
    Applicant
    Balance Ophthalmics, Inc.
    Date Received
    August 5, 2025
    Decision Date
    April 30, 2026
    Product Code
    QQJ
    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
    QQJ Applicator, Negative Pressure, External, Ocular

    Similar 510(k) Clearances

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

    FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System

    FDA 510(k)
    FDA Class 2 ·Ophthalmic
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    Other Clearances by Balance Ophthalmics, Inc.

    K Number Device Name
    DEN230055 FSYX™ Ocular Pressure Adjusting Pump (FSYX™ OPAP) System