K240564

NuFACE® FIX+

510(k) number
K240564
Device name
NuFACE® FIX+
Applicant
Carol Cole Company Dba Nuface® CA · US
Product code
NFO — Stimulator, Transcutaneous Electrical, Aesthetic Pur
Decision date
2024-06-27
Date received
2024-02-29
Decision
Substantially Equivalent
Clearance type
Traditional
Advisory committee
Neurology
PDFDownload 510(k) SummaryArchived here · 0.9 MB · U.S. public domain

Also available from FDA: K240564.pdf

Official FDA record: K240564
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.