Cleared Special

K061614 - TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS

K061614 is an FDA 510(k) clearance for TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ20..., manufactured by Escada International, Inc.. The device is a Class 2 Physical Medicine device with product code ILY cleared through the Special 510(k) pathway after a 119-day FDA review.

K061614 · Escada International, Inc. · Physical Medicine device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2006
Decision
119d
Days
Class 2
Risk

K061614 is an FDA 510(k) clearance for the TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS. Classified as Lamp, Infrared, Therapeutic Heating (product code ILY), Class II - Special Controls.

Submitted by Escada International, Inc. (North Attleboro, US). The FDA issued a Cleared decision on October 6, 2006 after a review of 119 days - within the typical 510(k) review window.

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.

FDA 510(k) Submission Details - K061614

510(k) Number K061614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 2006
Decision Date October 06, 2006
Days to Decision 119 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
3d slower than avg
Panel avg: 116d · This submission: 119d
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 222
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K061614 · TERRAQUANT MQ2000 V. 5 AND HANDYRX MQ2007 LASERS
Download PDF FDA Summary Escada International,…