BEUDAMED
    FDA Registration Active 🇺🇸 United States

    UltraClear Fractional Laser System

    Reg #: 3021550489 · FEI: 3021550489 · Expires 2025
    View on FDA
    Products
    2
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    2

    Registration Details

    Registration Name
    Acclaro Corporation
    Registration Number
    3021550489
    FEI Number
    3021550489
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    333 George washington hwy
    City
    Smithfield
    State
    RI
    ZIP
    02917
    Country
    US

    Regulatory Submissions

    510(k) Number
    K210847

    Owner / Operator

    Firm Name
    Acclaro Corporation
    Operator Number
    10084236
    Address
    333 George washington hwy
    City
    Smithfield
    State
    RI
    Postal Code
    02917
    Country
    US
    Correspondent
    David D Rothkopf

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG

    Proprietary Names

    UltraClear Fractional Laser System

    Establishment Types

    Manufacture Medical Device