Cleared Traditional

K082969 - LUMINEX INFRARED LAMP SYSTEM

K082969 is an FDA 510(k) clearance for LUMINEX INFRARED LAMP SYSTEM, manufactured by Medical Laser Systems, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K082969 · Medical Laser Systems, Inc. · Physical Medicine device
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Oct 2008
Decision
17d
Days
Class 2
Risk

K082969 is an FDA 510(k) clearance for the LUMINEX INFRARED LAMP SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Medical Laser Systems, Inc. (Washington, US). The FDA issued a Cleared decision on October 23, 2008 after a review of 17 days - a notably fast clearance 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: 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 Medical Laser Systems, Inc. devices

FDA 510(k) Submission Details - K082969

510(k) Number K082969 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 06, 2008
Decision Date October 23, 2008
Days to Decision 17 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 115d · This submission: 17d
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 39
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K082969.
THERMAPULSE
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ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6
K051922 · Cynosure, Inc. · Sep 2005