510(k) K234029— CEFALY Connected - OTC, CEFALY Connected - Rx

Substantially Equivalent

Cefaly Technology

Clearance details

Applicant: Cefaly Technology
Product code: Code PCC
Advisory panel: Neurology
Date received: 2023-12-20
Decision date: 2024-07-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Seraing, BE

Adverse events under product code PCC

product code PCC

Other: 1
Total: 1

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.