BEUDAMED
    FDA Registration Active 🇺🇸 United States

    LUMITHERA, INC.

    Reg #: 3016232028 · FEI: 3016232028 · Expires 2026
    View on FDA
    Products
    1
    Proprietary Names
    0
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    LUMITHERA, INC.
    Registration Number
    3016232028
    FEI Number
    3016232028
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    6201 South Fwy
    City
    Fort Worth
    State
    TX
    ZIP
    76134
    Country
    US

    Regulatory Submissions

    510(k) Number
    DEN230083

    Owner / Operator

    Firm Name
    Alcon Laboratories, Inc.
    Operator Number
    1610287
    Address
    6201 South Freeway
    City
    Fort Worth
    State
    TX
    Postal Code
    76134
    Country
    US

    Products

    Device Name Product Code
    Light Based Device For Dry Age-Related Macular Degeneration SDE

    Establishment Types

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