510(k) Report

FDA applicant

Cefaly Technology

Seraing, BE6 decisions2016–20240 recalls

FDA records 6 decisions for Cefaly Technology (Seraing, BE) from 2016 to 2024: 6 510(k) clearances. All are in product code PCC (Stimulator, Nerve, Electrical, Transcutaneous…). Its devices cite 8 predicates, 7 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Cefaly Technology’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2016: 12017: 22020: 12022: 12024: 1
2016high 2 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2016.

FIG. 1 — Cefaly Technology by year, 2016–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine6decisions

Whose devices does it build on?

Its devices cite 8 predicates; 7 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 16 times; 7 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K201895Cefaly DualCefaly Technology · 20205cite it
  • K160237CefalyCefaly Technology · 20164cite it
  • K173006Cefaly DualCefaly Technology · 20173cite it
  • K171446Cefaly AcuteCefaly Technology · 20172cite it
  • K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC…Cefaly Technology · 20221cites it
  • K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly Technology · 20241cites it

What has FDA decided for it lately?

  • K234029CEFALY Connected - OTC, CEFALY Connected - RxCefaly Technology · 2024
  • K212071Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC…Cefaly Technology · 2022
  • K201895Cefaly DualCefaly Technology · 2020
  • K173006Cefaly DualCefaly Technology · 2017
  • K171446Cefaly AcuteCefaly Technology · 2017
  • K160237CefalyCefaly Technology · 2016

All 6 as Cefaly Technology →