E.M.S. ELECTRO MEDICAL SYSTEMS S.A.

FDA Device Registration & Listing · NYON Vaud, CH · Registration 3004096429

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3004096429
FEI Number
3004096429
Entity Name
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
City/State/Country
NYON Vaud, CH
Establishment Address
RTE DE CHAMP-COLIN 2, NYON Vaud 1260, CH
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
E.M.S. ELECTRO MEDICAL SYSTEMS S.A. (Owner Number: 9057430)
Owner / Operator Contact Address
31 CH. DE LA VUARPILLIERE, --, NYON, VAUD, CH-NOTA CH-1260, CH
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K230893
PMA Number
N/A

All Registered Proprietary Names

SWISS LITHOCLAST TRILOGY AIR-FLOW POWDER AIR-FLOW HANDY 2+ OSSTEM BIK EMS SmartFibers Probe dia. 3.2 x 425 mm (9,6 Ch.) and SWISS LITHOCLAST MASTER Pneumatic Handpiece AIR-FLOW HANDY 3 PERIO GBT VISIGATE SWISS LITHOCLAST TRILOGY SWISS LITHOCLAST TRILOGY SWISS LITHOBREAKER LASERCLAST35 SWISS LITHOCLAST TRILOGY SWISS LITHOCLAST TRILOGY PERIO-FLOW NOZZLE LaserClast TM Fiber PIEZON BIK Lithovac lv3 Set Swiss DolorClast AIRFLOW PLUS POWDER AIR-FLOW HANDY 3 GBT Machine Airflow Prophylaxis Master Swiss LithoClast Trilogy System Kit - US Swiss LithoClast Trilogy Max System Kit

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2018-01-31
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2018-01-31
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2017-05-22
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2007-12-21
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2019-11-04
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-05-06
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2013-01-23
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2014-03-07
EIF Accessories, Retractor, Dental Dental Class 1 872.4565 2023-12-04
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2018-09-10
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2018-09-10
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2018-11-01
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2018-11-01
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2013-04-19
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-05-06
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2018-09-10
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2018-09-10
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2019-07-10
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2019-07-10
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2018-03-14
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-11-15
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2016-05-09
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2013-01-23
KQT Evacuator, Gastro-Urology Gastroenterology, Urology Class 2 876.4370 2013-01-23
NBN Generator, Shock-Wave, For Pain Relief Unknown Class 3 N/A 2007-08-23
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2018-03-14
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2014-04-25
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2026-01-29
KOJ Airbrush Dental Class 2 872.6080 2026-01-29
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2023-11-15
FEO Lithotriptor, Ultrasonic Gastroenterology, Urology Class 2 876.4480 2023-11-15

Official Correspondent

S. FASSIO-HARDY

US Agent Details

JEAN BAPTISTE AMADIEU Business: ELECTRO MEDICAL SYSTEMS, L.L.C. Email: jamadieu@ems-ch.com Phone: (972) 6908382

Related Public Records

Same Entity

E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
8030987 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. NYON Vaud, CH

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K885255 Candela Laser Corp. MDL-1 LASERTRIPTER(TM) 1989-06-01
K121698 Dentsply International, Inc. NUPRO SENSODYNE PROPHYLAXIS PASTE WITH NOVAMIN 2012-08-06
K212910 Shenzhen Carejoy Technology Co., Ltd. Dental High-speed Turbine Handpiece, Dental Low-speed Turbine Handpiece 2022-11-17
K832443 California Technics, Inc. ULTRASONIC DENTAL PROPHYLAXIS UNIT 1983-09-12
K994299 Bonart Co., Ltd. ART-P3, MODEL P3-1-ART-A1 2000-03-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA

Similar Registrations

Registration Number Establishment Name Location
3006617533 PROMEPLA S.A.M MONACO Monaco-Ville, MC
3010202439 Karl Storz Endoscopy-America, Inc. El Segundo, CA, US
8030987 E.M.S. ELECTRO MEDICAL SYSTEMS S.A. NYON Vaud, CH
2183744 Isomedix Operations, Inc. Minneapolis, MN, US
1648564 ELECTRO MEDICAL SYSTEMS, L.L.C. Southlake, TX, US
Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3004096429. Last updated year: 2026. Please use registration number 3004096429 when referencing this establishment in official correspondence.
Legal Disclaimer: AvaSpecs is not affiliated with the FDA or any government agency and does not provide medical, legal, regulatory, safety, approval, clearance, effectiveness, endorsement, or compliance advice. This index page is built using public record archives and does not represent an official regulatory determination.
Account Required Full available specs will require a free AvaSpecs account.