BEUDAMED
    FDA Registration Active 🇺🇸 United States

    EpilMe

    Reg #: 3015433394 · FEI: 3015433394 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    2
    Establishment Types
    2
    Classifications
    1

    Registration Details

    Registration Name
    NEAUVIA NORTH AMERICA, INC
    Registration Number
    3015433394
    FEI Number
    3015433394
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    Yes
    Address
    8480 Honeycutt Rd
    City
    Raleigh
    State
    NC
    ZIP
    27615
    Country
    US

    Regulatory Submissions

    510(k) Number
    K213261

    Owner / Operator

    Firm Name
    Neauvia North America
    Operator Number
    10061623
    Address
    8480 Honeycutt Rd
    City
    Raleigh
    State
    NC
    Postal Code
    27615
    Country
    US
    Correspondent
    Joy Willard

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    EpilMe ALIYA

    Establishment Types

    Develop Specifications But Do Not Manufacture At This Facility Complaint File Establishment per 21 CFR 820.198