Cleared Traditional

K142025 - NEUROLUMEN PN-1000

K142025 is an FDA 510(k) clearance for NEUROLUMEN PN-1000, manufactured by Neurolumen, LLC. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K142025 · Neurolumen, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
180d
Days
Class 2
Risk

K142025 is an FDA 510(k) clearance for the NEUROLUMEN PN-1000. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Neurolumen, LLC (Oklahoma City, US). The FDA issued a Cleared decision on January 21, 2015 after a review of 180 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 890.5500 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K142025

510(k) Number K142025 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2014
Decision Date January 21, 2015
Days to Decision 180 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
64d slower than avg
Panel avg: 116d · This submission: 180d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ILY Device Classification - Class 2, Special Controls

Product Code ILY Lamp, Infrared, Therapeutic Heating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 890.5500
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 Physical Medicine devices follow this clearance model.

Regulatory Consultant

Systec Engineering, LLC
ANDY THOMPSON

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 - ILY Lamp, Infrared, Therapeutic Heating

All 215
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K142025.
ZX2 Laser System
K150466 · Lzr7, Inc. · Jun 2015
HeatLux Pro I
K150175 · Home Skinovations , Ltd. · Mar 2015
QK-SYSTEMIC THERAPEUTIC APPARATUS
K141892 · Harbin Quanke Medi-Technical Development Co., Ltd. · Jan 2015
3B Laser 500, 3B Laser 200, LA-X P 500, LA-X P 200
K142722 · Livetec GmbH · Jan 2015
HILTHERA 4.0
K141861 · Jeisys Medical, Inc. · Jan 2015
Applied BioPhotonics Phototherapy System ABPT1003
K142256 · Applied Biophotonics , Ltd. · Jan 2015