Cleared Special

K252218 - MF SC GEN2 Facial Toning System (FDA 510(k) Clearance)

Class II Neurology device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252218 · Micro Current Technology, Inc. · Neurology device
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Jul 2025
Decision
3d
Days
Class 2
Risk

K252218 is an FDA 510(k) clearance for the MF SC GEN2 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, 2025 after a review of 3 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Micro Current Technology, Inc. devices

Submission Details

510(k) Number K252218 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 2025
Decision Date July 18, 2025
Days to Decision 3 days
Submission Type Special
Review Panel Neurology (NE)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
145d faster than avg
Panel avg: 148d · This submission: 3d
Pathway characteristics
Modification to existing cleared device. 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 Consultant

Regulatory Technology Services, LLC
Prithul Bom

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 74
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K252218.
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K252553 · Shenzhen Jianchao Intelligent Technology Co., Ltd. · Oct 2025