Cleared Special

K262861 - PureLift Pro Max

K262861 is an FDA 510(k) clearance for PureLift Pro Max, manufactured by Xtreem Pulse, LLC. The device is a Class 2 Neurology device with product code NFO cleared through the Special 510(k) pathway after a 29-day FDA review.

K262861 · Xtreem Pulse, LLC · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2026
Decision
29d
Days
Class 2
Risk

K262861 is an FDA 510(k) clearance for the PureLift Pro Max. Classified as Stimulator, Transcutaneous Electrical, Aesthetic Purposes (product code NFO), Class II - Special Controls.

Submitted by Xtreem Pulse, LLC (New York, US). The FDA issued a Cleared decision on September 11, 2026 after a review of 29 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 Xtreem Pulse, LLC devices

FDA 510(k) Submission Details - K262861

510(k) Number K262861 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 2026
Decision Date September 11, 2026
Days to Decision 29 days
Submission Type Special
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
120d faster than avg
Panel avg: 149d · This submission: 29d
Pathway characteristics
Modification to existing cleared device.

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 79
Devices cleared under the same product code (NFO) and FDA review panel - the closest regulatory comparables to K262861.
LED Light Therapy Masks (LED Face Mask Pulse (FAC06NA))
K261370 · Guangdong Newdermo Biotech Co., Ltd. · Sep 2026
FACEGYM Pro Device (HD-109)
K253932 · Shenzhen Kaiyan Medical Equipment Co., Ltd. · Jul 2026
VITA Multi-Function Head Brush (TB-2343F, TB-2442F)
K260179 · Touchbeauty Beauty & Health (Shenzhen) Co., Ltd. · Jun 2026
Ulike Clear Zero (YC10 BU)
K260895 · Guangxi Ulike Medical Technology Co., Ltd. · May 2026
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