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

FDA Device Registration & Listing · NYON Vaud, CH · Registration 8030987

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
8030987
FEI Number
3002806910
Entity Name
E.M.S. ELECTRO MEDICAL SYSTEMS S.A.
City/State/Country
NYON Vaud, CH
Establishment Address
31 CH. DE LA VUARPILLIERE, NYON Vaud CH-1260, CH
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198,Develop Specifications But Do Not Manufacture At This Facility
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
N/A
PMA Number
N/A

All Registered Proprietary Names

SWISS LITHOCLAST TRILOGY PERIO-FLOW NOZZLE AIR-FLOW HANDY 3 PERIO OSSTEM BIK Probe dia. 3.2 x 425 mm (9,6 Ch.) and SWISS LITHOCLAST MASTER Pneumatic Handpiece PIEZON BIK SWISS LITHOCLAST TRILOGY AIR-FLOW HANDY 2+ EMS SmartFibers DolorClast Radial EMS SmartFibers GBT Machine Airflow Prophylaxis Master SWISS LITHOCLAST SELECT SWISS LITHOCLAST ULTRA AIRFLOW PLUS POWDER SWISS LITHOCLAST TRILOGY AIR-FLOW HANDY 3 GBT FLOW CONTROL LaserClast TM Fiber LASERCLAST35 AIRFLOW PROPHYLAXIS MASTER, AIRFLOW ONE PIEZON 250 DOLORCLAST Focused Shock Waves SWISS LITHOCLAST TRILOGY AIR-FLOW POWDER

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
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
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2014-03-07
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2019-11-04
FFK Lithotriptor, Electro-Hydraulic Gastroenterology, Urology Class 2 876.4480 2013-01-23
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2016-05-09
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
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2007-12-21
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-05-06
ISA Massager, Therapeutic, Electric Physical Medicine Class 1 890.5660 2022-09-06
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-05-06
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 2013-01-23
EJR Agent, Polishing, Abrasive, Oral Cavity Dental Class 1 872.6030 2018-03-14
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
EFB Handpiece, Air-Powered, Dental Dental Class 1 872.4200 2014-04-25
EHZ Evacuator, Oral Cavity Dental Class 1 872.6640 2023-03-21
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-11-15
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2022-05-06
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2019-10-30
ELC Scaler, Ultrasonic Dental Class 2 872.4850 2014-01-23
PZL Extracorporeal Shock Wave Device For Treatment Of Diabetic Foot Ulcers General, Plastic Surgery Class 2 878.4685 2025-08-28
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

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
3004096429 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
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
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30

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

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2183744 Isomedix Operations, Inc. Minneapolis, MN, US
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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 8030987. Last updated year: 2026. Please use registration number 8030987 when referencing this establishment in official correspondence.
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