Cleared Traditional

K250361 - SmartAppGuidedTM MicroCurrent Face-Lift...

K250361 is an FDA 510(k) clearance for SmartAppGuidedTM MicroCurrent Face-Lift..., manufactured by Geske Beauty Tech GmbH. The device is a Class 2 Neurology device with product code NFO cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K250361 · Geske Beauty Tech GmbH · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2025
Decision
102d
Days
Class 2
Risk

K250361 is an FDA 510(k) clearance for the SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Geske Beauty Tech GmbH (Berlin, DE). The FDA issued a Cleared decision on May 23, 2025 after a review of 102 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 Geske Beauty Tech GmbH devices

FDA 510(k) Submission Details - K250361

510(k) Number K250361 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 10, 2025
Decision Date May 23, 2025
Days to Decision 102 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
46d faster than avg
Panel avg: 148d · This submission: 102d
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 K250361.
NeurotriS (SX2500)
K251909 · A-1 Engineering · Sep 2025
MF SC GEN2 Facial Toning System
K252218 · Micro Current Technology, Inc. · Jul 2025
Microcurrent Facial Device (CEC101, EE0101, EEI101)
K244004 · Shenzhen Dachi Communication Co., Ltd. · Jul 2025
Préime DermaFacial (MicroT)
K243072 · EMA Aesthetics , Ltd. · Apr 2025
PureLift GLOW
K243587 · Xtreem Pulse, LLC · Mar 2025
Myolight Microcurrent Handpiece
K243063 · Raja Trading Company, Inc. · Feb 2025