Cleared Traditional

K082223 - NEUTROLUMENPN SYSTEM, MODEL 1000

K082223 is an FDA 510(k) clearance for NEUTROLUMENPN SYSTEM, 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 258-day FDA review.

K082223 · Neurolumen, LLC · Physical Medicine device
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Apr 2009
Decision
258d
Days
Class 2
Risk

K082223 is an FDA 510(k) clearance for the NEUTROLUMENPN SYSTEM, MODEL 1000. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Neurolumen, LLC (Yukon, US). The FDA issued a Cleared decision on April 21, 2009 after a review of 258 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 - K082223

510(k) Number K082223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2008
Decision Date April 21, 2009
Days to Decision 258 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
142d slower than avg
Panel avg: 116d · This submission: 258d
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 Peers - ILY Lamp, Infrared, Therapeutic Heating

All 215
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