# E.M.S Electro Medical Systems S.A

- Location (FDA's records): Nyon, CH
- FDA decisions: 28 (2005–2026): 28 510(k) clearances
- Product codes: ELC (10), EFB (6), FEO (5), FFK (2), PZL (1), EBZ (1), ISA (1), EJR (1), DZI (1)
- 510(k) review time since 2016: median 106 days, against 112 for FDA's reviews in the same codes and years (4 of 8 faster)
- Predicates its devices cite: 43 (24 its own); citations of its devices by later devices: 44 (24 its own)
- Recalls linked to its devices: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Electro Medical Systems SA: 6 (https://510kreport.com/company/electro-medical-systems)
- (Ems Sa) Electro Medical Systems: 4 (https://510kreport.com/company/ems-sa-electro-medical-systems)
- Satelec: 3 (https://510kreport.com/company/satelec)
- Storz Medical AG: 2 (https://510kreport.com/company/storz-medical)
- Apoza Enterprise Co., Ltd.: 1 (https://510kreport.com/company/apoza-enterprise)
- The Laryngeal Mask Co., Ltd.: 1 (https://510kreport.com/company/laryngeal-mask)
- Electro Medical Systems (Ems Sa): 1 (https://510kreport.com/company/electro-medical-systems-ems)
- Piezosurgery S.R.L.: 1 (https://510kreport.com/company/piezosurgery)

## Firms that cite its devices most
- Nakanishi, Inc.: 3 (https://510kreport.com/company/nakanishi)
- Dmetec.Co., Ltd.: 3 (https://510kreport.com/company/dmetec)
- Guilin Woodpecker Medical Instrument Co., Ltd.: 2 (https://510kreport.com/company/guilin-woodpecker-medical-instrument)
- Sonendo, Inc.: 2 (https://510kreport.com/company/sonendo)
- Satelec: 2 (https://510kreport.com/company/satelec)
- 3M Deutschland GmbH: 1 (https://510kreport.com/company/3m-deutschland)
- Coltene/Whaledent, Inc.: 1 (https://510kreport.com/company/coltene-whaledent)
- BTL Industries, Inc.: 1 (https://510kreport.com/company/btl-industries)

## Its most-cited devices
- K093000: Ems Piezon Master 700 (2010), cited by 7
- K082791: Ems Air-Flow Master (2009), cited by 6
- K110173: Ems Air-Flow Master Piezon (2011), cited by 6
- K092289: Ems Air-Flow Handy Perio (2009), cited by 4
- K190124: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One (2019), cited by 3
- K050710: Minimaster Ultrasonic Scaler (2005), cited by 2

## Recent decisions
- K253254: GBT Machine Airflow Prophylaxis Master (Jan 28, 2026)
- K243279: DOLORCLAST Focused Shock Waves (Aug 13, 2025)
- K230893: Swiss LthoClast Trilogy (Oct 23, 2023)
- K220538: DolorClast Radial (Jul 11, 2022)
- K190124: EMS AIRFLOW Prophylaxis Master, EMS AIRFLOW One (Oct 20, 2019)
- K191079: Piezon Built-in Kit, Piezon Built-in Kit LED (Aug 16, 2019)
- K191124: Swiss LithoClast Trilogy (May 29, 2019)
- K182490: Swiss LithoClast Trilogy (Oct 9, 2018)

Source page: https://510kreport.com/company/ems-electro-medical-systems-s-a