Cleared Special

K070974 - LIGHT RELIEF, MODEL LR150, LR200

K070974 is an FDA 510(k) clearance for LIGHT RELIEF, manufactured by Light Relief, LLC. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Special 510(k) pathway after a 48-day FDA review.

K070974 · Light Relief, LLC · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2007
Decision
48d
Days
Class 2
Risk

K070974 is an FDA 510(k) clearance for the LIGHT RELIEF, MODEL LR150, LR200. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Light Relief, LLC (Los Angeles, US). The FDA issued a Cleared decision on May 24, 2007 after a review of 48 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.

FDA 510(k) Submission Details - K070974

510(k) Number K070974 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 2007
Decision Date May 24, 2007
Days to Decision 48 days
Submission Type Special
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
68d faster than avg
Panel avg: 116d · This submission: 48d
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 227
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K070974 · LIGHT RELIEF, MODEL LR150, LR200
Download PDF FDA Summary Light Relief, LLC