Cleared Traditional

MF SC Facial Toning System (K233525) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K233525 · Micro Current Technology, Inc. · Neurology device
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Nov 2023
Decision
23d
Days
Class 2
Risk

K233525 is an FDA 510(k) clearance for the MF SC Facial Toning System. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Micro Current Technology, Inc. (Seattle, US). The FDA issued a Cleared decision on November 24, 2023 after a review of 23 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Micro Current Technology, Inc. devices

Submission Details

510(k) Number K233525 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 01, 2023
Decision Date November 24, 2023
Days to Decision 23 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
125d faster than avg
Panel avg: 148d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

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 50
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K233525.
NuFACE® FIX+
K240564 · Carol Cole Company Dba Nuface · Jun 2024
BEAR 2 Body
K232242 · Foreo, Inc. · May 2024
Facial Toning device (UIC-189)
K233667 · Body Trim Industrial Co., Ltd. · Feb 2024
Nu Skin RenuSpa iO
K232001 · Nse Products, Inc. · Nov 2023
Beagank 4T Plus
K233010 · Belega, Inc. · Nov 2023
C.C. Life 21
K230459 · 21 Equipment S.R.L. · Oct 2023