BEUDAMED
    FDA Registration Active 🇺🇸 United States

    GALDERMA LABORATORIES, L.P.

    Reg #: 1000118068 · FEI: 1000118068 · Expires 2026
    View on FDA
    Products
    4
    Proprietary Names
    17
    Establishment Types
    1
    Classifications
    4

    Registration Details

    Registration Name
    GALDERMA LABORATORIES, L.P.
    Registration Number
    1000118068
    FEI Number
    1000118068
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    14600 Heritage Pkwy
    City
    Fort Worth
    State
    TX
    ZIP
    76177
    Country
    US

    Regulatory Submissions

    510(k) Number
    K110850
    PMA Number
    P030050

    Owner / Operator

    Firm Name
    Galderma Laboratories, L.P.
    Operator Number
    10047852
    Address
    14600 Heritage Parkway
    City
    Fort Worth
    State
    TX
    Postal Code
    76177
    Country
    US
    Correspondent
    Randy Russell

    Products

    Device Name Product Code
    Implant, Dermal, For Aesthetic Use LMH
    Dressing, Wound, Occlusive NAD
    Implant, Dermal, For Aesthetic Use In The Hands PKY
    Needle, Hypodermic, Single Lumen FMI

    Proprietary Names

    Sculptra Aesthetic Sculptra Differin Power Patch Skin Restore Differin Acne-Prone Skin Patches Differin Power Patch Fast Fix Cetaphil Fast Rescue Pimple Patch Restylane-L Restylane Restylane Lyft with Lidocaine Restylane Silk Perlane Restylane Eyelight Restylane Defyne Restylane Refyne Restylane Kysse Restylane Contour Terumo 27 G TW Needle

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198