# Bemer Int AG

- Location (FDA's records): Triesen, LI
- FDA decisions: 4 (2017–2023): 4 510(k) clearances
- Product codes: NGX (3), OHS (1)
- 510(k) review time since 2016: median 149 days, against 105 for FDA's reviews in the same codes and years (2 of 4 faster)
- Predicates its devices cite: 8 (3 its own); citations of its devices by later devices: 11 (3 its own)
- Recalls linked to its devices: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Actegy, Ltd.: 1 (https://510kreport.com/company/actegy)
- Shenzhen Kaiyan Medical CO, Ltd.: 1 (https://510kreport.com/company/shenzhen-kaiyan-medical)
- Globalmed Technologies: 1 (https://510kreport.com/company/globalmed-technologies)
- Johnson & Johnson Consumer, Inc.: 1 (https://510kreport.com/company/johnson-johnson-consumer)
- Cellreturn Co., Ltd.: 1 (https://510kreport.com/company/cellreturn)

## Firms that cite its devices most
- Eywa Srl: 2 (https://510kreport.com/company/eywa)
- Aura Wellness, LLC: 2 (https://510kreport.com/company/aura-wellness)
- Shenzhen Dachi Communication Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-dachi-communication)
- Storz Medical AG: 1 (https://510kreport.com/company/storz-medical)
- Shenzhen Ulike Smart Electronics Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-ulike-smart-electronics)
- Quantumtx Pte., Ltd.: 1 (https://510kreport.com/company/quantumtx)

## Its most-cited devices
- K151834: BEMER Classic Set, BEMER Pro-Set (2017), cited by 5
- K210174: BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set (2021), cited by 4
- K223919: B.Light Clear Evo and B.Light Restore Evo (2023), cited by 2

## Recent decisions
- K223919: B.Light Clear Evo and B.Light Restore Evo (Sep 23, 2023)
- K231368: Bemer Therapy System Evo (Jun 9, 2023)
- K210174: BEMER Therapy Systems, BEMER Classic Set, BEMER Pro-Set (Feb 4, 2021)
- K151834: BEMER Classic Set, BEMER Pro-Set (Feb 22, 2017)

Source page: https://510kreport.com/company/bemer-int