Cleared Traditional

Ultra Facial Toning System (K181062) - FDA 510(k) Clearance

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

K181062 · Micro Current Technology, Inc. · Neurology device
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Jul 2018
Decision
86d
Days
Class 2
Risk

K181062 is an FDA 510(k) clearance for the Ultra 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 July 18, 2018 after a review of 86 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 K181062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 2018
Decision Date July 18, 2018
Days to Decision 86 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
62d faster than avg
Panel avg: 148d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Consultant

Regulatory Insight, Inc.
David Suzuki

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

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 K181062.
Ultra OTC Facial Toning System
K183189 · Micro Current Technology, Inc. · Apr 2019
NuFACE FIX Skin Toning Device
K182424 · Carol Cole Company Dba Nuface · Dec 2018
NuFACE Trinity
K181008 · Carol Cole Company Dba Nuface · Oct 2018
TAMA BEMS device
K173093 · Tama Research Corporation · Jun 2018
2 Face / Face Evolution
K171821 · Heat IN A Click · Apr 2018