BEUDAMED
    FDA Registration Active 🇺🇸 United States

    FSYX Ocular Pressure Adjusting Pump

    Reg #: 3027866078 · FEI: 3027866078 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    Balance Ophthalmics, Inc.
    Registration Number
    3027866078
    FEI Number
    3027866078
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    3101 W 57th Street
    City
    Sioux Falls
    State
    SD
    ZIP
    57108
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN230055

    Owner / Operator

    Firm Name
    Balance Ophthalmics, Inc.
    Operator Number
    10088563
    Address
    3101 W 57th Street
    City
    Sioux Falls
    State
    SD
    Postal Code
    57108
    Country
    US
    Correspondent
    Gary Mocnik

    Products

    Device Name Product Code
    Applicator, Negative Pressure, External, Ocular QQJ

    Proprietary Names

    FSYX Ocular Pressure Adjusting Pump

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility