Cleared Traditional

K150554 - NuBrilliance Light Pain Therapy

K150554 is an FDA 510(k) clearance for NuBrilliance Light Pain Therapy, manufactured by Wellquest International, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 216-day FDA review.

K150554 · Wellquest International, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2015
Decision
216d
Days
Class 2
Risk

K150554 is an FDA 510(k) clearance for the NuBrilliance Light Pain Therapy. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Wellquest International, Inc. (New York, US). The FDA issued a Cleared decision on October 6, 2015 after a review of 216 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 - K150554

510(k) Number K150554 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 04, 2015
Decision Date October 06, 2015
Days to Decision 216 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
100d slower than avg
Panel avg: 116d · This submission: 216d
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

Emergo Global Consulting, LLC
CARRIE HETRICK

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 K150554.
Elysiom Polychromatic LED Light Therapy (PLLT) System (Elysiom)
K153389 · In Light Wellness Systems, Inc. · Mar 2016
BioPhotas Celluma3
K152280 · Biophotas, Inc. · Mar 2016
Varaya Sport
K150716 · Varaya Photoceuticals, LLC · Dec 2015
Phoenix Thera-Lase System
K151521 · Phoenix Thera-Lase Systems, LLC · Sep 2015
LightStim for Pain LED Belt
K151333 · Led Intellectual Properties, LLC · Aug 2015
ZX2 Laser System
K150466 · Lzr7, Inc. · Jun 2015