BEUDAMED
    FDA Registration Active 🇺🇸 United States

    JEISYS MEDICAL NORTH AMERICA INC

    Reg #: 3033715699 · FEI: 3033715699 · Expires 2026
    View on FDA
    Products
    6
    Proprietary Names
    11
    Establishment Types
    1
    Classifications
    6

    Registration Details

    Registration Name
    JEISYS MEDICAL NORTH AMERICA INC
    Registration Number
    3033715699
    FEI Number
    3033715699
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    70 Blanchard Rd Ste 303
    City
    Burlington
    State
    MA
    ZIP
    01803
    Country
    US

    Regulatory Submissions

    510(k) Number
    K201685

    Owner / Operator

    Firm Name
    JEISYS MEDICAL NORTH AMERICA INC
    Operator Number
    10091463
    Address
    70 Blanchard Road, Suite 303
    City
    Burlington
    State
    MA
    Postal Code
    01803
    Country
    US
    Correspondent
    Sarah Dunne

    Products

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

    Proprietary Names

    Potenza SmoothCool TRI-BEAM PRO, TRI-BEAM DENSITY; DENSITY Noir; DENZA SmoothCool HR system Intracel Pro Lipocel DENSITY DENSITY Noir DENZA EdgeOne

    Establishment Types

    Complaint File Establishment per 21 CFR 820.198