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)
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.

View all Escada International, Inc. devices

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
Regulatory Context
Review time vs. panel average
4d slower than avg
Panel avg: 115d · 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 39
Devices cleared under the same product code (ILY) and FDA review panel - the closest regulatory comparables to K061614.
THERMAPULSE
K092222 · Palomar Medical Products, Inc. · Aug 2009
AKLARUS PHOTOTHERAPY SYSTEM
K083183 · Hill Laboratories Co. · Jul 2009
EZLASE
K083595 · Biolase Technology, Inc. · Apr 2009
DYNATRON DX2 TRACTION UNIT
K051680 · Dynatronics Corp. · Oct 2005
HILT FAMILY LASER: HILT I, HILT II, HILT III
K051537 · Cynosure, Inc. · Sep 2005
ASA 'M FAMILY' DIODE LASER, MODEL MI, MIX5, M6
K051922 · Cynosure, Inc. · Sep 2005