BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ML830 Smart Laser

    Reg #: 3000985188 · FEI: 3000985188 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    ITI Manufacturing Inc.
    Registration Number
    3000985188
    FEI Number
    3000985188
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    333 Southwestern Blvd Ste 202
    City
    Sugar Land
    State
    TX
    ZIP
    77478
    Country
    US

    Regulatory Submissions

    510(k) Number
    K010175

    Owner / Operator

    Firm Name
    ITI Manufacturing Inc.
    Operator Number
    10031312
    Address
    333 Southwestern Blvd, Suite 202
    City
    Sugar Land
    State
    TX
    Postal Code
    77479
    Country
    US
    Correspondent
    Daniel Wu

    Products

    Device Name Product Code
    Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy NHN

    Proprietary Names

    ML830 Smart Laser

    Establishment Types

    Manufacture Medical Device for Another Party (Contract Manufacturer)