Cleared Traditional

K260895 - Ulike Clear Zero (YC10 BU) (FDA 510(k) Clearance)

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

K260895 · Guangxi Ulike Medical Technology Co., Ltd. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2026
Decision
71d
Days
Class 2
Risk

K260895 is an FDA 510(k) clearance for the Ulike Clear Zero (YC10 BU). Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Guangxi Ulike Medical Technology Co., Ltd. (Yulin, CN). The FDA issued a Cleared decision on May 28, 2026 after a review of 71 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 Guangxi Ulike Medical Technology Co., Ltd. devices

Submission Details

510(k) Number K260895 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 2026
Decision Date May 28, 2026
Days to Decision 71 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
77d faster than avg
Panel avg: 148d · This submission: 71d
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 76
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K260895.
DeepSkin (DEP100)
K252621 · El Global Trade, Ltd. · May 2026
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