Cleared Traditional

K250361 - SmartAppGuidedTM MicroCurrent Face-Lift Pen 6 in 1 (FDA 510(k) Clearance)

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

K250361 · Geske Beauty Tech GmbH · Neurology device
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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

Submission Details

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.

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 74
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K250361.
Multi-functional Facial Beauty Device ( SKB-1703,SKB-1803,SKB-1909, SKB-2003 SKB-2109,SKB-2129,SKB-2208PRO, SKB-2209)
K252146 · Shenzhen Siken 3D Technology Development Co., Ltd. · Dec 2025
Aura Glide (FC40)
K252187 · Aura Medical, LLC · Dec 2025
Medi Lift Essential Eye Mask
K250618 · Ya-Man, Ltd. · Oct 2025
JOVS Electric Stimulation Beauty Device (JE2)
K250227 · Shenzhen Qianyu Technology Co., Ltd. · Oct 2025
Radiant Renewal Skincare Lid (HD-59A, HD-59B, HD-70)
K251034 · Shenzhen Nuon Medical Equipment Co., Ltd. · Oct 2025
Facial & Body Beauty Device (INIA-BD001, INIA-BD002, INIA-BD003, INIA-BD004, F2C15, F3222 Pro, F5516, F3606, F2210 Pro, F5808, INIA-ED001, INIA-ED002, INIA-BLD001, E1507)
K252553 · Shenzhen Jianchao Intelligent Technology Co., Ltd. · Oct 2025