BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Carol Cole Company dba NuFACE

    Reg #: 3006459199 · FEI: 3006459199 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    19
    Establishment Types
    4
    Classifications
    3

    Registration Details

    Registration Name
    Carol Cole Company dba NuFACE
    Registration Number
    3006459199
    FEI Number
    3006459199
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    1325 Sycamore Ave Ste B
    City
    Vista
    State
    CA
    ZIP
    92081
    Country
    US

    Regulatory Submissions

    510(k) Number
    K181008

    Owner / Operator

    Firm Name
    Carol Cole Company
    Operator Number
    9106439
    Address
    1325 Sycamore Ave Ste B, --
    City
    Vista
    State
    CA
    Postal Code
    92081
    Country
    US
    Correspondent
    Kimberly - Morales

    Products

    Device Name Product Code
    Stimulator, Transcutaneous Electrical, Aesthetic Purposes NFO
    Light Based Over The Counter Wrinkle Reduction OHS
    Media, Electroconductive GYB

    Proprietary Names

    Labeling Information Pilot Program Participants Only Trinity Wrinkle Reducer Trinity Wrinkle Remover NuFACE Mini Facial and Neck Skin Toning Device NuFACE FIX Device FIX MicroWand (FIX+) Trinity Plus Facial Toning Device NuFACE Trinity Facial Toning Device Micro Dermal Tone MDT Professional Home Care Device NuFACE Mini+ NuFACE Classic NuFACE Trinity ELE+ Pro NuFACE Trinity ELE+ NuFACE Mini NuFACE Trinity+ Wrinkle Reducer NuFACE Gel Primer Trinity ELE NuFACE Trinity+ NuFACE Trinity + Facial and Neck Toning

    Establishment Types

    Manufacture Medical Device Repack or Relabel Medical Device Complaint File Establishment per 21 CFR 820.198 Develop Specifications But Do Not Manufacture At This Facility