BEUDAMED
    FDA Registration Active 🇺🇸 United States

    Lutronic Aesthetics, Inc.

    Reg #: 3006247712 · FEI: 3006247712 · Expires 2026
    View on FDA
    Products
    3
    Proprietary Names
    2
    Establishment Types
    1
    Classifications
    3

    Registration Details

    Registration Name
    Lutronic Aesthetics, Inc.
    Registration Number
    3006247712
    FEI Number
    3006247712
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    3/5 Carlisle Road
    City
    Westford
    State
    MA
    ZIP
    01886
    Country
    US

    Regulatory Submissions

    510(k) Number
    K251327

    Owner / Operator

    Firm Name
    Lutronic Aesthetics, Inc.
    Operator Number
    9058403
    Address
    3/5 Carlisle Road
    City
    Westford
    State
    MA
    Postal Code
    01886
    Country
    US
    Correspondent
    Sean Reynolds

    Products

    Device Name Product Code
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Powered Laser Surgical Instrument GEX

    Proprietary Names

    XERF eCO2 3D

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198