510(k) Report

510(k) · Cleared

Cleared

Terraquant MQ2000 Laser Therapy Device

K043055510(k) TraditionalCleared Jul 25, 2005262-day reviewClass II21 CFR 890.5500

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Escada International, Inc. · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Jul 25, 2005 as substantially equivalent to K032229 (Quantum Devices, Inc., 2003) after a 262-day review. Its family tree reaches back 2 generations to 1998. 19 later devices descend from it.

Decided
Jul 25, 2005
Review
262 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
1

Its longest line of descent runs back 2 generations to K974468 (1998). 4 ancestors in all. 19 later devices descend from it, 2 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1998: 1 other ancestor2006: 1 descendant cleared2008: 1 descendant cleared2015: 5 descendants cleared2009: 1 descendant cleared2012: 1 descendant cleared2016: 2 descendants cleared2017: 1 descendant cleared2022: 1 descendant cleared2026: 4 descendants cleared2025: 2 descendants clearedK974468 · Photonic Stimulator · Bales Scientific, Inc. · 1998K032229 · Quantum Warp 10 Light Delivery System · Quantum Devices, Inc. · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 2 generations back: 2 other ancestors 1 generation forward: 2 descendants2 generations forward: 2 descendants3 generations forward: 4 descendants4 generations forward: 7 descendants5 generations forward: 4 descendants K032229 · Quantum Warp 10 Light Delivery System · Quantum Devices, Inc. · 2003K974468 · Photonic Stimulator · Bales Scientific, Inc. · 19980+5
  1. Root · 2 generations backK974468 Photonic StimulatorBales Scientific, Inc. · 1998
  2. 1 generation backK032229 Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003
  3. This deviceK043055 Terraquant MQ2000 Laser Therapy DeviceEscada International, Inc. · 2005
  4. Descendant · cites it directly · 17 of its ownK061614 Terraquant MQ2000 V. 5 and Handyrx MQ2007 LasersEscada International, Inc. · 2006
  5. Descendant · 2 generations on · 15 of its ownK083580 Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC · 2009
  6. Descendant · 3 generations on · 10 of its ownK150098 LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015
  7. Descendant · 3 generations on · 4 of its ownK151333 LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015
  8. Descendant · 3 generations on · 3 of its ownK153399 LightStim Professional LED BedLed Intellectual Properties, LLC · 2016

Showing 5 of 19 descendants. See all descendants

Descendants cleared per year

2006: 12008: 12009: 12012: 12015: 52016: 22017: 12022: 12025: 22026: 4
2006high 5 (2015) · low 0 (2007)2026

Most influential descendants

Showing 5 of 19 · See all
  • K061614Terraquant MQ2000 V. 5 and Handyrx MQ2007 LasersEscada International, Inc. · 2006 · cites it directly17descendants
  • K083580Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC · 2009 · 2 generations on15descendants
  • K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015 · 3 generations on10descendants
  • K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015 · 3 generations on4descendants
  • K153399LightStim Professional LED BedLed Intellectual Properties, LLC · 2016 · 3 generations on3descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−2K974468Photonic StimulatorBales Scientific, Inc.1998—
−1K032229Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc.2003—
0 (this device)K043055Terraquant MQ2000 Laser Therapy DeviceEscada International, Inc.2005—
+1K061614Terraquant MQ2000 V. 5 and Handyrx MQ2007 LasersEscada International, Inc.2006—
+2K083580Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC2009—
+3K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC2015—
+3K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC2015—
+3K153399LightStim Professional LED BedLed Intellectual Properties, LLC2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200610
200810
200910
201210
201550
201620
201710
202210
202520
202640
FIG. 1 — Lineage of K043055, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in ILY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new ILY device

  1. #1 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K032229Quantum Warp 10 Light Delivery System
Summary page 1
…Therapy Device Common/Usual Name: heating lamp Classification Name: Infrared lamp 3. PREDICATE DEVICES Quantum WARP 10 Light Delivery System - K032229 4. DEVICE DESCRIPTION The TerraQuant MQ2000 is a non-invasive pain therapy system, which utilizes heating lam…
Quantum Devices, Inc.2003—

Also cleared against K032229: 14 other devices →

What descends from it? (19)

See all 19

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K061614Terraquant MQ2000 V. 5 and Handyrx MQ2007 LasersEscada International, Inc.200617
K080689Spectra Therapy System A1000 Laser DevicePremier Dynamics, Inc.20080

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 7 years and passes through 3 companies; a new generation was cleared every 5.2 years on median.
  • None of the 4 ancestors has a recall.
  • Of its descendants, K061614 (Escada International, Inc., 2006) has gone furthest, with 17 descendants of its own.
  • 14 other devices also cite its predicate K032229.

How does its category compare?

All ILY devices

ILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · ILY

1in 2025

2007: 102008: 162009: 132010: 82011: 92012: 112013: 92014: 112015: 112016: 82017: 52020: 12022: 22023: 12024: 12025: 12026 (partial year): 1
2007high 16 (2008) · low 0 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · ILY

116in 2017

2007: 128 days median2008: 165 days median2009: 189 days median2010: 185 days median2011: 198 days median2012: 130 days median2013: 211 days median2014: 153 days median2015: 146 days median2016: 214 days median2017: 116 days median
2007high 214 (2016) · low 116 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · ILY

1in 2025

2010: 12012: 32022: 42023: 12025: 12026 (partial year): 1
2007high 4 (2022) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · ILY

17in 2025

2007: 242008: 202009: 92010: 72011: 102012: 72013: 82015: 22016: 22017: 122018: 12019: 72020: 52021: 52022: 22023: 152024: 192025: 17
2007high 24 (2007) · low 0 (2014)2025

MAUDE reports naming product code ILY, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200710128024
200816165020
20091318909
2010818517
20119198010
20121113037
2013921108
20141115300
20151114602
2016821402
20175116012
20180—01
20190—07
20201—05
20210—05
20222—42
20231—115
20241—019
20251—117
20261—1—

What is it indicated for?

The TerraQuant MQ2000 is a non-invasive infrared lamp intended to provide topical heating. The Terraquant MQ2000 is indicated for temporary relief of minor muscle and joint pain, arthritis and muscle spasm, relieving stiffness, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation where heat is indicated.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K043055: Terraquant MQ2000 Laser Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043055

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026