BEUDAMED
    FDA Registration Active 🇰🇷 South Korea

    JEISYS MEDICAL INC.

    Reg #: 3006985163 · FEI: 3006985163 · Expires 2026
    View on FDA
    Products
    8
    Proprietary Names
    21
    Establishment Types
    1
    Classifications
    8

    Registration Details

    Registration Name
    JEISYS MEDICAL INC.
    Registration Number
    3006985163
    FEI Number
    3006985163
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    No
    Address
    307, 308, 401, 410, Daeryung Techno Town 8th, 96 Gamasan-ro, Geumcheon-gu
    City
    Seoul
    Country
    KR

    Regulatory Submissions

    510(k) Number
    K100098

    Owner / Operator

    Firm Name
    Jeisys Medical Inc.
    Operator Number
    10025329
    Address
    307, 308, 401, 410, Daeryung Techno Town 8th, 96 Gamasan-ro, Geumcheon-gu
    City
    Seoul
    State
    KR-NOTA
    Postal Code
    08501
    Country
    KR
    Correspondent
    Hirshnzon Avi

    US Agent

    Business Name
    Jeisys Medical North America
    Contact Name
    Sarah Dunne
    Address
    70 Blanchard Rd Ste 303
    City
    Burlington
    State
    MA
    ZIP
    01803
    Country
    US
    Email
    [email protected]
    Phone
    781 2616904

    Products

    Device Name Product Code
    Powered Laser Surgical Instrument GEX
    Electrosurgical, Cutting & Coagulation & Accessories GEI
    Skin Resurfacing Rf Applicator OUH
    Powered Light Based Non-Laser Surgical Instrument With Thermal Effect ONF
    Powered Laser Surgical Instrument With MicrobeamFractional Output ONG
    Lamp, Infrared, Therapeutic Heating ILY
    Focused Ultrasound For Tissue Heat Or Mechanical Cellular Disruption OHV
    Motor, Surgical Instrument, Ac-Powered GEY

    Proprietary Names

    PlasmaLipo / Plasma D30 POTENZA SmoothCool INTRAcel SmoothCool HR System TRI-BEAM PRO, TRI-BEAM Edge Hilthera 4 Therapeutical Laser System 800, 700, 640, 590, 560, 545(V), 530, 530(D), 530(s), 500(s), 420(s) NEW Handpiece, 560nm(S) Handpiece, 700nm(S) Handpiece, 700nm(L) Handpiece Edge ONE TRI-BEAM LIPOcel INTRAcel PRO P-Nain System DENZA DENSITY DENSITY Noir SmoothCool HR Sysetm DENSITY, DENSITY Noir, DENZA D'Liv

    Establishment Types

    Manufacture Medical Device