Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in BelgiumLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under its name, each linked to the record.
As of Nov 13, 2026, FDA's public records list Cefaly Technology with 6 510(k) clearances. The most recent is a 510(k) clearance dated Jul 18, 2024: CEFALY Connected - OTC, CEFALY Connected - Rx.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Date | Record | Source |
|---|---|---|
| Jul 18, 2024 | CEFALY Connected - OTC, CEFALY Connected - RxK234029 · PCC | 510(k) clearances |
| Dec 13, 2022 | Cefaly Dual Enhanced with RFID - OTC, Cefaly Dual Enhanced with RFID - Rx, Cefaly Dual Connected - OTC, Cefaly Dual Connected - RxK212071 · PCC | 510(k) clearances |
| Sep 29, 2020 | Cefaly DualK201895 · PCC | 510(k) clearances |
| Nov 28, 2017 | Cefaly DualK173006 · PCC | 510(k) clearances |
| Sep 15, 2017 | Cefaly AcuteK171446 · PCC | 510(k) clearances |
| Mar 4, 2016 | CefalyK160237 · PCC | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
