BEUDAMED
    FDA Registration Active 🇺🇸 United States

    ELECTRO MEDICAL SYSTEMS, L.L.C.

    Reg #: 1648564 · FEI: 3000205943 · Expires 2026
    View on FDA
    Products
    10
    Proprietary Names
    34
    Establishment Types
    2
    Classifications
    10

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    Registration Details

    Registration Name
    ELECTRO MEDICAL SYSTEMS, L.L.C.
    Registration Number
    1648564
    FEI Number
    3000205943
    Status
    Active
    Expiry Year
    2026
    Initial Importer
    Yes
    Address
    2150E Continental Boulevard
    City
    Southlake
    State
    TX
    ZIP
    76092
    Country
    US

    Regulatory Submissions

    510(k) Number
    K072146
    PMA Number
    P050004

    Owner / Operator

    Firm Name
    ELECTRO MEDICAL SYSTEMS, INC.
    Operator Number
    9025157
    Address
    2150 E Continental Blvd
    City
    Southlake
    State
    TX
    Postal Code
    76092
    Country
    US
    Correspondent
    Jean-Baptiste AMADIEU

    Products

    Device Name Product Code
    Drill, Bone, Powered DZI
    Scaler, Ultrasonic ELC
    Handpiece, Air-Powered, Dental EFB
    Agent, Polishing, Abrasive, Oral Cavity EJR
    Lithotriptor, Electro-Hydraulic FFK
    Lithotriptor, Ultrasonic FEO
    Evacuator, Gastro-Urology KQT
    Massager, Therapeutic, Electric ISA
    Scaler, Rotary ELB
    Generator, Shock-Wave, For Pain Relief NBN

    Proprietary Names

    Piezon Master Surgery Piezon Master 700 AIR-FLOW S2 AIR-FLOW MASTER PIEZON Swiss LithoClast Trilogy EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One AIR-FLOW handy 3 PLUS EMS PIEZON 707 BIK PIEZON BUILT-IN KIT - S5 BIK, S5 BIK T; PIEZON BUILT-IN KIT LED - S5L BIK, S5L BIK T LITHOCLAST MASTER HANDPIECE & 3.2MM PROBE AIR-FLOW PLUS Prophylaxis Powder; AIRFLOW PLUS AIR-FLOW CLASSIC Prophylaxis Powder; AIR-FLOW PERIO Prophylaxis Powder; AF SOFT Prophylaxis Powder; AF COMFORT; AF PERIO ASPIRATION PROBE; LITHOPUMP; LITHOVAC SUCTION LITHOVAC SUCTION, ASPIRATION PROBE, LITHOPUMP AIR-FLOW handy 3 Piezon Master 600 Handpiece only DOLORCLAST RADIAL miniMaster SWISS LITHOCLAST; SWISS LITHOCLAST MASTER; SWISS LITHOCLAST SELECT; SWISS LITHOCLAST ULTRA AIR-FLOW HANDY PERIO AIR-FLOW MASTER PERIO AIR-FLOW HANDY 2+ LITHOTRIPTOR, ELECTRO-HYDRAULIC LITHOTRIPTOR, ULTRASONIC PERIO-FLOW Nozzle MiniEndo III SWISS DOLORCLAST ORTHOPEDIC R Swiss LITHOCLAST Lithotripter SWISS LITHOCLAST MASTER, SWISS LITHOCLAST ULTRA, SWISS LITHOCLAST SELECT Piezon 250 Piezon 150 miniPiezon AIR-FLOW handy 3 PERIO miniMaster LED

    Establishment Types

    Remanufacture Medical Device Repack or Relabel Medical Device