BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Restylane Refyne

    Reg #: 1000118068 · FEI: 1000118068 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    4
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    GALDERMA LABORATORIES, L.P.
    Registration Number
    1000118068
    FEI Number
    1000118068
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    2001 Ross Ave Suite 1600
    City
    Dallas
    State
    TX
    ZIP
    75201
    Country
    US

    Regulatory Submissions

    PMA Number
    P140029

    Owner / Operator

    Firm Name
    Galderma Laboratories, L.P.
    Operator Number
    10047852
    Address
    2001 Ross Ave Suite 1600
    City
    Dallas
    State
    TX
    Postal Code
    75201
    Country
    US
    Correspondent
    Randy Russell

    Products

    Device Name Product Code
    Implant, Dermal, For Aesthetic Use LMH

    Proprietary Names

    Restylane Refyne Restylane Defyne Restylane Contour Restylane Kysse

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198