BEUDAMED
    FDA Registration Active 🇺🇸 United States

    SL-Z3-LED

    Reg #: 3004441848 · FEI: 3004441848 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    24
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    S4OPTIK LLC
    Registration Number
    3004441848
    FEI Number
    3004441848
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    11825 Central Parkway
    City
    Jacksonville
    State
    FL
    ZIP
    32224
    Country
    US

    Regulatory Submissions

    510(k) Number
    K992836

    Owner / Operator

    Firm Name
    S4OPTIK LLC
    Operator Number
    9077083
    Address
    11825 Central Parkway
    City
    Jacksonville
    State
    FL
    Postal Code
    32224
    Country
    US
    Correspondent
    Matthew - McKenna

    Products

    Device Name Product Code
    Biomicroscope, Slit-Lamp, Ac-Powered HJO

    Proprietary Names

    SL-Z3-LED SL-H5 - LED SL-H5 ELITE HD-LED SL-Z5 - DIGITAL READY - LED SL-H3-LED SL-H2 SL-Z3 - DIGITAL READY - LED SL-HZ - ZOOM - DIGITAL READY - LED SL-Z3 SL-Z5 SL-H3-DIGITAL READY-LED SL-ZZ - DIGITAL READY - LED SL-Z2 SL-HZ - ZOOM - LED SL-HZ - ZOOM SL-H5 - DIGITAL READY-LED SL-ZZ - ZOOM - LED SL-Z2-LED SL 990 SL-H2-LED SL-Z5-LED SL 9800 SL 980 SL 9900

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198