Cleared Special

TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM (K080102) - FDA 510(k) Clearance

Class II Physical Medicine device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K080102 · Escada International, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
219d
Days
Class 2
Risk

K080102 is an FDA 510(k) clearance for the TQ SOLO AND SOLO PRO AND LS50 ACCESSORY AND MR4 MULTI RADIANCE THERAPY SYSTEM. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Escada International, Inc. (Littleton, US). The FDA issued a Cleared decision on August 20, 2008 after a review of 219 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. 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. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Escada International, Inc. devices

Submission Details

510(k) Number K080102 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 2008
Decision Date August 20, 2008
Days to Decision 219 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
104d slower than avg
Panel avg: 115d · This submission: 219d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 228
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