510(k) Report

510(k) · Cleared

Cleared

Quantum Warp 10 Light Delivery System

K032229510(k) TraditionalCleared Sep 12, 200353-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

Quantum Devices, Inc. · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Sep 12, 2003 as substantially equivalent to K022888 (Light Force Therapy, Inc., 2002) and 2 other predicates after a 53-day review. Its family tree reaches back 1 generation to 1998. 198 later devices descend from it.

Decided
Sep 12, 2003
Review
53 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
3

Its longest line of descent runs back 1 generation to K974468 (1998). 3 ancestors in all. 198 later devices descend from it, 15 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor1998: 1 other ancestor2004: 1 descendant cleared2011: 3 descendants cleared2005: 7 descendants cleared2007: 2 descendants cleared2012: 7 descendants cleared2009: 4 descendants cleared2006: 3 descendants cleared2008: 6 descendants cleared2017: 9 descendants cleared2010: 6 descendants cleared2015: 8 descendants cleared2016: 4 descendants cleared2025: 44 descendants cleared2013: 5 descendants cleared2019: 3 descendants cleared2021: 10 descendants cleared2022: 10 descendants cleared2026: 24 descendants cleared2014: 3 descendants cleared2018: 4 descendants cleared2020: 5 descendants cleared2023: 13 descendants cleared2024: 17 descendants clearedK974468 · Photonic Stimulator · Bales Scientific, Inc. · 19981995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors 1 generation forward: 15 descendants2 generations forward: 22 descendants3 generations forward: 27 descendants4 generations forward: 26 descendants5 generations forward: 27 descendants6 generations forward: 40 descendants7 generations forward: 33 descendants8 generations forward: 7 descendants9 generations forward: 1 descendant K974468 · Photonic Stimulator · Bales Scientific, Inc. · 19980+5
  1. Root · 1 generation backK974468 Photonic StimulatorBales Scientific, Inc. · 1998
  2. This deviceK032229 Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003
  3. Descendant · cites it directly · 171 of its ownK043317 Omnilux PlusPhoto Therapeutics Limited · 2005
  4. Descendant · 2 generations on · 160 of its ownK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
  5. Descendant · 2 generations on · 115 of its ownK060792 IllumimedPhotoactif, LLC · 2006
  6. Descendant · 2 generations on · 91 of its ownK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
  7. Descendant · 2 generations on · 91 of its ownK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008

Showing 5 of 198 descendants. See all descendants

Descendants cleared per year

2004: 12005: 72006: 32007: 22008: 62009: 42010: 62011: 32012: 72013: 52014: 32015: 82016: 42017: 92018: 42019: 32020: 52021: 102022: 102023: 132024: 172025: 442026: 24
2004high 44 (2025) · low 1 (2004)2026

Most influential descendants

Showing 5 of 198 · See all
  • K043317Omnilux PlusPhoto Therapeutics Limited · 2005 · cites it directly171descendants
  • K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005 · 2 generations on160descendants
  • K060792IllumimedPhotoactif, LLC · 2006 · 2 generations on115descendants
  • K083183Aklarus Phototherapy SystemHill Laboratories Co. · 2009 · 2 generations on91descendants
  • K072459Omnilux New-UPhoto Therapeutics, Inc. · 2008 · 2 generations on91descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K974468Photonic StimulatorBales Scientific, Inc.1998—
0 (this device)K032229Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc.2003—
+1K043317Omnilux PlusPhoto Therapeutics Limited2005—
+2K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005—
+2K060792IllumimedPhotoactif, LLC2006—
+2K083183Aklarus Phototherapy SystemHill Laboratories Co.2009—
+2K072459Omnilux New-UPhoto Therapeutics, Inc.2008—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200410
200570
200630
200720
200860
200940
201060
201130
201270
201350
201430
201580
201640
201790
201840
201930
202050
2021100
2022100
2023130
2024170
2025440
2026240
FIG. 1 — Lineage of K032229, 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
Get a 510(k) Report

What was it cleared against? (3)

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
*K022888Acubeam, Super Nova, Dio
Summary page 5
…01-1 Part 425 (L1.2601-1) Substantial Equivalence: The Quantum WARP 10 Light Delivery System is substantially equivalent 1o the: Light Force Therapy Inc., Super Nova - K022888 Bales Scientific Inc., Photomic Stimulator - K974468 DioMedics Inc., Pain-X-2000 Model 5700 — K982546 The Quantuin Device, Ine.…
Light Force Therapy, Inc.2002—
*K974468Photonic Stimulator
Summary page 5
…he Quantum WARP 10 Light Delivery System is substantially equivalent 1o the: Light Force Therapy Inc., Super Nova - K022888 Bales Scientific Inc., Photomic Stimulator - K974468 DioMedics Inc., Pain-X-2000 Model 5700 — K982546 The Quantuin Device, Ine. Quantum WARP 10 is substantially equivalent to these…
Bales Scientific, Inc.1998—
*K982546Phaser-2000
Summary page 5
…antially equivalent 1o the: Light Force Therapy Inc., Super Nova - K022888 Bales Scientific Inc., Photomic Stimulator - K974468 DioMedics Inc., Pain-X-2000 Model 5700 — K982546 The Quantuin Device, Ine. Quantum WARP 10 is substantially equivalent to these products in thatithas the same intended use and s…
Diomedics, Inc.1998—

Also cleared against K022888: 7 other devices →

What descends from it? (198)

See all 198

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

NumberDeviceApplicantDecidedDescendants
K043317Omnilux PlusPhoto Therapeutics Limited2005171
K042813Biobeam Narrow Band Light Therapy DevicesLife Without Pain, LLC200522
K043055Terraquant MQ2000 Laser Therapy DeviceEscada International, Inc.200519
K083580Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC200915
K042532Biocare Systems Premir 818Biocare Systems, Inc.20048
K090008Tanda Restore, Model PtscsPharos Life Corporation20096
K101716HVR Pain Relief DeviceH.V.R., Inc.20115
K120582HeatluxHome Skinovations, Ltd.20123
K112494Varaya AR , Varaya SportVaraya Photoceuticals, LLC20121
K110558CS1000 Light Therapy DeviceGenesis Health Light Corporation20120

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?

  • None of the 3 ancestors has a recall.
  • Of its descendants, K043317 (Photo Therapeutics Limited, 2005) has gone furthest, with 171 descendants of its own.
  • 7 other devices also cite its predicate K022888.

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 Quantum WARP 10 Light Delivery System is a hand held device used for the treatment of chronic pain by emitting energy in the Near-IR spectrum for the 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 applied.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

Also cleared against K022888

7 other devices cite the same predicate.

  • K083580Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC · 2009
  • K070690The Life VesselCottonwood Vessel Corporation · 2007
  • K052492Airnergy+StreamNatural Energy Solutions AG · 2006
  • K043317Omnilux PlusPhoto Therapeutics Limited · 2005
  • K042813Biobeam Narrow Band Light Therapy DevicesLife Without Pain, LLC · 2005
  • K042532Biocare Systems Premir 818Biocare Systems, Inc. · 2004

More from Quantum Devices, Inc.

2 FDA decisions under this applicant name. See the company

  • K113231WARP10,WARP75Quantum Devices, Inc. · 2012

Recent decisions in ILY

The ILY category page

  • K253965CureLight Medical Diode Laser Systems (CureLight F2-A15; CureLight F2-B15; CureLight F2-A30; CureLight…Wuhan PHOMED Technology Company, Ltd. · 2026
  • K242755Medical Diode Laser Systems (VELAS II-30B, VELAS II-30A, GBOX-15AB, GBOX-20B, CHEESE II-10B)Gigaalaser Company, Ltd. · 2025
  • K231997SIRONA 100 Therapy Laser System (OEM's Model EVANLAS)Cure Point Therapeutics, Inc. · 2024
  • K223642LED Lip Perfector, model: ZC-05Light Tree Ventures Europe B.V. · 2023
  • K221189Oliz LTB-1000ALtbio Co., Ltd. · 2022

https://510kreport.com/device/K032229 · printed Nov 4, 2026

Cite this page

510(k) Report. “K032229: Quantum Warp 10 Light Delivery System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K032229

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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