# Cefaly Technology

- Location (FDA's records): Seraing, BE
- FDA decisions: 6 (2016–2024): 6 510(k) clearances
- Product codes: PCC (6)
- Predicates its devices cite: 8 (7 its own); citations of its devices by later devices: 16 (7 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Stx-Med Sprl: 1 (https://510kreport.com/company/stx-med-sprl)

## Firms that cite its devices most
- Nu Eyne Co., Ltd.: 2 (https://510kreport.com/company/nu-eyne)
- Ybrain, Inc.: 1 (https://510kreport.com/company/ybrain)
- Wat Medical Technology, Inc.: 1 (https://510kreport.com/company/wat-medical-technology)
- Soterix Medical, Inc.: 1 (https://510kreport.com/company/soterix-medical)
- Shenzhen Dongdixin Technology Co., Ltd.: 1 (https://510kreport.com/company/shenzhen-dongdixin-technology)
- Neurolief, Ltd.: 1 (https://510kreport.com/company/neurolief)
- Wat Medical Technology (Ningbo) Co., Ltd.: 1 (https://510kreport.com/company/wat-medical-technology-ningbo)
- Hinge Health, Inc.: 1 (https://510kreport.com/company/hinge-health)

## Its most-cited devices
- K201895: Cefaly Dual (2020), cited by 5
- K160237: Cefaly (2016), cited by 4
- K173006: Cefaly Dual (2017), cited by 3
- K171446: Cefaly Acute (2017), cited by 2
- K212071: Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx (2022), cited by 1
- K234029: CEFALY Connected - OTC, CEFALY Connected - Rx (2024), cited by 1

## Recent decisions
- K234029: CEFALY Connected - OTC, CEFALY Connected - Rx (Jul 18, 2024)
- K212071: Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - Rx (Dec 13, 2022)
- K201895: Cefaly Dual (Sep 29, 2020)
- K173006: Cefaly Dual (Nov 28, 2017)
- K171446: Cefaly Acute (Sep 15, 2017)
- K160237: Cefaly (Mar 4, 2016)

Source page: https://510kreport.com/company/cefaly-technology