Cleared Special

K051816 - LUMIWAVE 1X4 INFRARED THERAPY DEVICE

K051816 is an FDA 510(k) clearance for LUMIWAVE 1X4 INFRARED THERAPY DEVICE, manufactured by Biocare Systems, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Special 510(k) pathway after a 52-day FDA review.

K051816 · Biocare Systems, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
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Aug 2005
Decision
52d
Days
Class 2
Risk

K051816 is an FDA 510(k) clearance for the LUMIWAVE 1X4 INFRARED THERAPY DEVICE. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Biocare Systems, Inc. (Denver, US). The FDA issued a Cleared decision on August 26, 2005 after a review of 52 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. 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 Biocare Systems, Inc. devices

FDA 510(k) Submission Details - K051816

510(k) Number K051816 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2005
Decision Date August 26, 2005
Days to Decision 52 days
Submission Type Special
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
63d faster than avg
Panel avg: 115d · This submission: 52d
Pathway characteristics
Modification to existing cleared device.

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 56
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