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510(k) Data Aggregation
K Number
K240564Device Name
NuFACE® FIX+
Manufacturer
Carol Cole Company dba NuFACE®
Date Cleared
2024-06-27
(119 days)
Product Code
NFO
Regulation Number
882.5890Why did this record match?
Applicant Name (Manufacturer) :
Carol Cole Company dba NuFACE®
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The NuFACE FIX+ Device is intended for facial stimulation and is indicated for over-the-counter cosmetic use.
Device Description
FIX+ is a portable hand-held microcurrent stimulator for facial skin stimulation indicated for over-the-counter cosmetic use. Main components: Main unit, USB power cable, and NuFACE Line Smoothing FIX Serum conductivity gel. Housing of the device made from Acrylonitrile Butadiene Styrene, with chrome-plated spherical probes. Inclusion of three microcurrent output frequency levels. Integrated rechargeable lithium-ion battery.
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