Data / Medical devices / Switzerland / E.M.S. Electro Medical Systems S.A.
E.M.S. Electro Medical Systems S.A.: FDA-registered device maker in NYON Vaud, Switzerland, 25 510(k) clearances and 1 PMA approval
E.M.S. Electro Medical Systems S.A. is registered with the FDA (registration 3004096429) in NYON Vaud, Switzerland. It lists 12 device types. The FDA files 25 510(k) clearances and 1 PMA approval under its listings, the newest dated January 28, 2026. 1 recall event names it as the recalling firm. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 3004096429
- Address
- Rte De Champ-Colin 2, NYON Vaud, Switzerland, 1260
- Owner or operator
- E.M.S. ELECTRO MEDICAL SYSTEMS S.A. (9057430)
- Roles
- Exporter to the US, Manufacturer, Repackager or relabeler
- First device listed
- August 23, 2007
- Registered through
- 2026
- Brand names listed
- AIR-FLOW HANDY 2+, AIR-FLOW HANDY 3, AIR-FLOW HANDY 3 PERIO, AIR-FLOW POWDER, AIRFLOW PLUS POWDER, AIRFLOW PROPHYLAXIS MASTER, AIRFLOW ONE, DolorClast Radial, EMS SmartFibers and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Accessories, Retractor, Dental | EIF | 1 | Exporter to the US | accessdata.fda.gov |
| Agent, Polishing, Abrasive, Oral Cavity | EJR | 1 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Airbrush | KOJ | 2 | Manufacturer | accessdata.fda.gov |
| Evacuator, Gastro-Urology | KQT | 2 | Manufacturer | accessdata.fda.gov |
| Evacuator, Oral Cavity | EHZ | 1 | Manufacturer | accessdata.fda.gov |
| Generator, Shock-Wave, For Pain Relief | NBN | 3 | Manufacturer | accessdata.fda.gov |
| Handpiece, Air-Powered, Dental | EFB | 1 | Exporter to the US, Manufacturer | accessdata.fda.gov |
| Lithotriptor, Electro-Hydraulic | FFK | 2 | Manufacturer | accessdata.fda.gov |
| Lithotriptor, Ultrasonic | FEO | 2 | Manufacturer | accessdata.fda.gov |
| Massager, Therapeutic, Electric | ISA | 1 | Manufacturer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US, Repackager or relabeler | accessdata.fda.gov |
| Scaler, Ultrasonic | ELC | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| January 28, 2026 | K253254 | GBT Machine Airflow Prophylaxis Master | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| October 23, 2023 | K230893 | Swiss LthoClast Trilogy | FEO | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| July 11, 2022 | K220538 | DolorClast Radial | ISA | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| March 16, 2022 | K220426 | Fiber Dust PRO | GEX | Substantially Equivalent | Quanta System Spa | accessdata.fda.gov |
| December 20, 2019 | K192990 | Litho Evo | GEX | Substantially Equivalent | Quanta System Spa | accessdata.fda.gov |
| October 20, 2019 | K190124 | EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| August 16, 2019 | K191079 | Piezon Built-in Kit, Piezon Built-in Kit LED | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| May 29, 2019 | K191124 | Swiss LithoClast Trilogy | FFK | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| October 9, 2018 | K182490 | Swiss LithoClast Trilogy | FEO | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| August 30, 2018 | K181997 | Swiss LithoClast Trilogy | FEO | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| June 20, 2018 | K181364 | Swiss LithoClast Trilogy | FEO | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| January 10, 2018 | K173234 | Swiss LithoClast Trilogy | FEO | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| December 18, 2017 | K171174 | PERIO-FLOW nozzle | EFB | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| September 11, 2017 | K171189 | AIR-FLOW PLUS Prophylaxis powder | EJR | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| March 18, 2016 | K160513 | Quanta System Surgical Laser fibers | GEX | Substantially Equivalent | Quanta System Spa | accessdata.fda.gov |
| February 27, 2015 | K140990 | EMS PIEZON 707 BIK AND PIEZON 707 BIK LED | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| April 11, 2014 | K132478 | AIR-FLOW HANDY 3.0 | EFB | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| February 24, 2014 | K132480 | AIR-FLOW HANDY 3.0 PERIO | EFB | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| December 6, 2013 | K132445 | PIEZON 250 | ELC | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| October 24, 2013 | K131473 | (QUANTA SYSTEM) SURGICAL LASER FIBERS | GEX | Substantially Equivalent | Quanta System Spa | accessdata.fda.gov |
| January 16, 2013 | K123038 | SWISS LITHOBREAKER | FFK | Substantially Equivalent | E.M.S Electro Medical Systems S.A | accessdata.fda.gov |
| July 25, 2002 | K022119 | EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE | EFB | Substantially Equivalent | Electro Medical Systems SA | accessdata.fda.gov |
| August 24, 2001 | K012445 | EMS SWISS LITHOCLAST MASTER (A.K.A. SWISS LITHOCLAST ULTRA) | FFK | Substantially Equivalent | Electro Medical Systems SA | accessdata.fda.gov |
| December 18, 1997 | K974164 | SWISS LITHOCLAST MASTER HANDPIECE AND 3.2 MM PROBE | FFK | Substantially Equivalent | Medical Device Consultants, Inc. | accessdata.fda.gov |
| December 16, 1996 | K964111 | LITHOVAC SUCTION/ASPIRATION PROBE | KQT | Substantially Equivalent | Electro Medical Systems SA | accessdata.fda.gov |
PMA approvals
Premarket approvals this establishment lists, with the supplements the FDA has decided since.
| Approved | PMA number | Device | Product code | Supplements | Latest decision | Source |
|---|---|---|---|---|---|---|
| May 8, 2007 | P050004 | EMS SWISS DOLORCLAST | NBN | 1 | August 28, 2009 | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| October 3, 2003 | 27447 | Not yet classified | Terminated | LithoClast Foot Pedal, reference EK-166 Catalog Number: Used as an accessory to the EMS Swiss LithoClast Master/Ultra, Catalog No.. Manufactured by EMS Electro Medical Systems S, Nyon, Switzerland. Distributed by Boston | Failure of foot pedal to activate device | accessdata.fda.gov |
Compare with other makers
- All makers of Agent, Polishing, Abrasive, Oral Cavity
- All makers of Powered Laser Surgical Instrument
- All makers of Scaler, Ultrasonic
- All makers of Airbrush
- All makers of Lithotriptor, Electro-Hydraulic
- All makers of Lithotriptor, Ultrasonic
Updated January 28, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.