510(k) Report

510(k) · Cleared

Cleared

Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301

K083580510(k) TraditionalCleared Jun 22, 2009201-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

Led Intellectual Properties, LLC · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Jun 22, 2009 as substantially equivalent to K032229 (Quantum Devices, Inc., 2003) and 3 other predicates after a 201-day review. Its family tree reaches back 4 generations to 1998. 15 later devices descend from it.

Decided
Jun 22, 2009
Review
201 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
4

Its longest line of descent runs back 4 generations to K974468 (1998). 7 ancestors in all. 15 later devices descend from it, 4 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2005: 1 other ancestor2002: 1 other ancestor1998: 1 other ancestor2015: 4 descendants 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. · 2003K043055 · Terraquant MQ2000 Laser Therapy Device · Escada International, Inc. · 2005K061614 · Terraquant MQ2000 V. 5 and Handyrx MQ2007 Lasers · Escada International, Inc. · 20061995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 2 other ancestors2 generations back: 1 other ancestor 1 generation forward: 4 descendants2 generations forward: 7 descendants3 generations forward: 4 descendants K061614 · Terraquant MQ2000 V. 5 and Handyrx MQ2007 Lasers · Escada International, Inc. · 2006K043055 · Terraquant MQ2000 Laser Therapy Device · Escada International, Inc. · 2005K032229 · Quantum Warp 10 Light Delivery System · Quantum Devices, Inc. · 2003K974468 · Photonic Stimulator · Bales Scientific, Inc. · 19980
  1. Root · 4 generations backK974468 Photonic StimulatorBales Scientific, Inc. · 1998
  2. 3 generations backK032229 Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003
  3. 2 generations backK043055 Terraquant MQ2000 Laser Therapy DeviceEscada International, Inc. · 2005
  4. 1 generation backK061614 Terraquant MQ2000 V. 5 and Handyrx MQ2007 LasersEscada International, Inc. · 2006
  5. This deviceK083580 Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC · 2009
  6. Descendant · cites it directly · 10 of its ownK150098 LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015
  7. Descendant · cites it directly · 4 of its ownK151333 LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015
  8. Descendant · cites it directly · 3 of its ownK153399 LightStim Professional LED BedLed Intellectual Properties, LLC · 2016
  9. Descendant · cites it directly · 3 of its ownK120582 HeatluxHome Skinovations, Ltd. · 2012
  10. Descendant · 2 generations on · 1 of its ownK260129 Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026

Showing 5 of 15 descendants. See all descendants

Descendants cleared per year

2012: 12015: 42016: 22017: 12022: 12025: 22026: 4
2012high 4 (2015) · low 0 (2013)2026

Most influential descendants

Showing 5 of 15 · See all
  • K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC · 2015 · cites it directly10descendants
  • K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC · 2015 · cites it directly4descendants
  • K153399LightStim Professional LED BedLed Intellectual Properties, LLC · 2016 · cites it directly3descendants
  • K120582HeatluxHome Skinovations, Ltd. · 2012 · cites it directly3descendants
  • K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd. · 2026 · 2 generations on1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K974468Photonic StimulatorBales Scientific, Inc.1998—
−3K032229Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc.2003—
−2K043055Terraquant MQ2000 Laser Therapy DeviceEscada International, Inc.2005—
−1K061614Terraquant MQ2000 V. 5 and Handyrx MQ2007 LasersEscada International, Inc.2006—
0 (this device)K083580Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC2009—
+1K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC2015—
+1K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC2015—
+1K153399LightStim Professional LED BedLed Intellectual Properties, LLC2016—
+1K120582HeatluxHome Skinovations, Ltd.2012—
+2K260129Lumaflex Panel (ZLD-05, ZLD-05A, ZLD-05APro )Shenzhen Kaiyan Medical Equipment Co., Ltd.2026—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200210
200510

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201540
201620
201710
202210
202520
202640
FIG. 1 — Lineage of K083580, 1998–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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? (4)

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 2
…is device is substantially equivalent to the following predicate devices, which are currently in safe and effective commerce: 1. Quantum Warp 10 Light Delivery System — K032229 2. Pain Relief Bio-Beam 660+940 & Med Light 1630+2630 — K042813 3. Terra Quant MQ2000 V.5 & handy Rx MQ2007 - K061614 4. Acubea…
Quantum Devices, Inc.2003—
*K042813Biobeam Narrow Band Light Therapy Devices
Summary page 2
…devices, which are currently in safe and effective commerce: 1. Quantum Warp 10 Light Delivery System — K032229 2. Pain Relief Bio-Beam 660+940 & Med Light 1630+2630 — K042813 3. Terra Quant MQ2000 V.5 & handy Rx MQ2007 - K061614 4. Acubeam, Super Nova, Dio — K022888 6. Performance Standards: These de…
Life Without Pain, LLC2005—
*K061614Terraquant MQ2000 V. 5 and Handyrx MQ2007 Lasers
Summary page 2
…merce: 1. Quantum Warp 10 Light Delivery System — K032229 2. Pain Relief Bio-Beam 660+940 & Med Light 1630+2630 — K042813 3. Terra Quant MQ2000 V.5 & handy Rx MQ2007 - K061614 4. Acubeam, Super Nova, Dio — K022888 6. Performance Standards: These devices have been tested under and are in compliance wit…
Escada International, Inc.2006—
*K022888Acubeam, Super Nova, Dio
Summary page 2
…ry System — K032229 2. Pain Relief Bio-Beam 660+940 & Med Light 1630+2630 — K042813 3. Terra Quant MQ2000 V.5 & handy Rx MQ2007 - K061614 4. Acubeam, Super Nova, Dio — K022888 6. Performance Standards: These devices have been tested under and are in compliance with performance standards that have been…
Light Force Therapy, Inc.2002—

Also cleared against K032229: 14 other devices →

What descends from it? (15)

See all 15

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

NumberDeviceApplicantDecidedDescendants
K150098LightStim Professional 2-Panel LightLed Intellectual Properties, LLC201510
K151333LightStim for Pain LED BeltLed Intellectual Properties, LLC20154
K153399LightStim Professional LED BedLed Intellectual Properties, LLC20163
K120582HeatluxHome Skinovations, Ltd.20123

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 11 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
  • None of the 7 ancestors has a recall.
  • Of its descendants, K150098 (Led Intellectual Properties, LLC, 2015) has gone furthest, with 10 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. 2009, this device’s year, is highlighted.

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 Pain Therapy Light, model: PTL, is an Over-The-Counter hand held device intended to emit energy in the visible and near infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for a temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain or muscle spasm, the temporary increase in local and blood circulation, and the temporary relaxation of muscles.

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

Cite this page

510(k) Report. “K083580: Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K083580

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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