Cleared Traditional

K240564 - NuFACE FIX+

K240564 is an FDA 510(k) clearance for NuFACE FIX+, manufactured by Carol Cole Company Dba Nuface. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 119-day FDA review.

K240564 · Carol Cole Company Dba Nuface · Neurology device
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Jun 2024
Decision
119d
Days
Class 2
Risk

K240564 is an FDA 510(k) clearance for the NuFACE® FIX+. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Carol Cole Company Dba Nuface (Vista, US). The FDA issued a Cleared decision on June 27, 2024 after a review of 119 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5890 - the FDA neurology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Carol Cole Company Dba Nuface devices

FDA 510(k) Submission Details - K240564

510(k) Number K240564 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 29, 2024
Decision Date June 27, 2024
Days to Decision 119 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
29d faster than avg
Panel avg: 148d · This submission: 119d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

NFO Device Classification - Class 2, Special Controls

Product Code NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Neurology devices follow this clearance model.

Regulatory Peers - NFO Stimulator, Transcutaneous Electrical, Aesthetic Purposes

All 53
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K240564.
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BTL-785BNF-E
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K232242 · Foreo, Inc. · May 2024
Facial Toning device (UIC-189)
K233667 · Body Trim Industrial Co., Ltd. · Feb 2024
MF SC Facial Toning System
K233525 · Micro Current Technology, Inc. · Nov 2023