BEUDAMED
    FDA Registration Active 🇨🇳 China

    RHEIN LASER TECHNOLOGIES CO., LTD.

    Reg #: 3026038437 · FEI: 3026038437 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    15
    Establishment Types
    2
    Classifications
    6

    Registration Details

    Registration Name
    RHEIN LASER TECHNOLOGIES CO., LTD.
    Registration Number
    3026038437
    FEI Number
    3026038437
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    6F, B2-A Building, No.999 High-Tech Avenue, Future City, East Lake High-Tech Development Zone
    City
    wuhan Hubei
    Country
    CN

    Regulatory Submissions

    510(k) Number
    K233756

    Owner / Operator

    Firm Name
    Rhein Laser Technologies Co., Ltd.
    Operator Number
    10087178
    Address
    801,8F, E2 Building,Future City, No.999 High-Tech Avenue, East Lake High-Tech Development Zone, 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 E Apt 14
    City
    Clearwater
    State
    FL
    ZIP
    33763
    Country
    US
    Email
    [email protected]
    Phone
    720 5894939

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Laser For Disruption Of Adipocyte Cells For Aesthetic Use PKT
    Powered Light Based Laser Non-Thermal Instrument With Non-Heating Effect For Adjunctive Use In Pain Therapy NHN
    Lamp, Infrared, Therapeutic Heating ILY
    Apparatus, Cell-Freezing And Reagents KSP
    Massager, Therapeutic, Electric ISA

    Proprietary Names

    Artemis Diode Laser System(RL-S20S-TWC,RL-S20S-810B,RL-S20S-755) Powersculp laser lipolysis system PowerCure/PowerCure PRO Therapy Device PowerCure, PowerCure PRO. PowerCure Pulse Therapy System DL-1300mW Therapy System MateRobot Laser Therapy System 1300mW Handheld Laser Smart Therapy System TheraLight 360 Full Body Wellness (ineraLignt 360+, ineraLight 10X,TheraLight FIT,TheraLight 360,TheraLight THIN) TitanPico Laser Workstation (PICO-450) Medical Thulium Fiber Laser System CO2-CRYO Cryo Therapy System SWAVE-200 shockwave therapy machine PMST,PMST NEO, Electromagnetic Stimulation System Focused Shockwave 200

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198 Manufacture Medical Device