Cefaly— 510(k) K160237

Substantially Equivalent

Cefaly Technology

FDA 510(k) clearance K160237 for Cefaly, Substantially Equivalent on 2016-03-04. Applicant: Cefaly Technology.

Clearance details

Applicant: Cefaly Technology
Product code: Code PCC
Advisory panel: Neurology
Date received: 2016-02-01
Decision date: 2016-03-04
Decision: Substantially Equivalent
Clearance type: Special
Location: Herstal, BE

Download summary PDF View on FDA.gov ↗

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.