BEUDAMED
    FDA Registration Active 🇨🇳 China

    PowerSculp laser lipolysis system

    Reg #: 3012294783 · FEI: 3012294783 · Expires 2025
    View on FDA
    Products
    1
    Proprietary Names
    1
    Establishment Types
    1
    Classifications
    1

    Registration Details

    Registration Name
    WUHAN LOTUXS TECHNOLOGY CO.,LTD.
    Registration Number
    3012294783
    FEI Number
    3012294783
    Status
    Active
    Expiry Year
    2025
    Initial Importer
    No
    Address
    5F, E2 Building, No.999 Gaoxin Avenue, Future City,, East Lake High-tech Development Zone, Wuhan ,China
    City
    Wuhan Hubei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K191068

    Owner / Operator

    Firm Name
    Wuhan Lotuxs Technology Co.,Ltd.
    Operator Number
    10051850
    Address
    501/E2, Future city, No.999 high-tech Avenue, Wuhan 430206, China(Free Trade Zone/Wuhan Area)
    City
    Wuhan
    State
    Hubei
    Postal Code
    430206
    Country
    CN
    Correspondent
    Shelly Mao

    US Agent

    Business Name
    BraunSolutions Regulatory Group
    Contact Name
    Alexander Henderson
    Address
    2298 Americus Blvd East, Unit 14
    City
    Clearwater
    State
    FL
    ZIP
    33763
    Country
    US
    Email
    [email protected]
    Phone
    720 5894939

    Products

    Device Name Product Code
    Laser For Disruption Of Adipocyte Cells For Aesthetic Use PKT

    Proprietary Names

    PowerSculp laser lipolysis system

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198