NuFACE® FIX+— 510(k) K240564

Substantially Equivalent

Carol Cole Company Dba Nuface®

FDA 510(k) clearance K240564 for NuFACE® FIX+, Substantially Equivalent on 2024-06-27. Applicant: Carol Cole Company Dba Nuface®. Device class: 2.

Clearance details

Applicant
Carol Cole Company Dba Nuface®
Product code
Code NFO
Device class
Class 2
Regulation
21 CFR 882.5890
Advisory panel
Neurology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Vista, CA, US
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