Cleared Special

K103511 - LITECURE THERAPY SYSTEM

K103511 is an FDA 510(k) clearance for LITECURE THERAPY SYSTEM, manufactured by Litecure, LLC. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Special 510(k) pathway after a 56-day FDA review.

K103511 · Litecure, LLC · Physical Medicine device
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Jan 2011
Decision
56d
Days
Class 2
Risk

K103511 is an FDA 510(k) clearance for the LITECURE THERAPY SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Litecure, LLC (Newark, US). The FDA issued a Cleared decision on January 25, 2011 after a review of 56 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 Litecure, LLC devices

FDA 510(k) Submission Details - K103511

510(k) Number K103511 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 30, 2010
Decision Date January 25, 2011
Days to Decision 56 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
59d faster than avg
Panel avg: 115d · This submission: 56d
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 31
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