510(k) Report

510(k) · Cleared

Cleared

Omnilux Plus

K043317510(k) TraditionalCleared Mar 15, 2005103-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

Photo Therapeutics Limited · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Mar 15, 2005 as substantially equivalent to K974468 (Bales Scientific, Inc., 1998) and 4 other predicates after a 103-day review. Its family tree reaches back 2 generations to 1998. 171 later devices descend from it.

Decided
Mar 15, 2005
Review
103 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
5

Its longest line of descent runs back 2 generations to K974468 (1998). 5 ancestors in all. 171 later devices descend from it, 10 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2002: 1 other ancestor2000: 1 other ancestor1998: 1 other ancestor2008: 3 descendants cleared2017: 8 descendants cleared2009: 2 descendants cleared2012: 3 descendants cleared2005: 1 descendant cleared2010: 6 descendants cleared2006: 1 descendant cleared2015: 4 descendants cleared2013: 5 descendants cleared2011: 2 descendants cleared2019: 3 descendants cleared2016: 3 descendants cleared2021: 10 descendants cleared2014: 3 descendants cleared2018: 4 descendants cleared2020: 5 descendants cleared2022: 10 descendants cleared2023: 13 descendants cleared2024: 17 descendants cleared2025: 44 descendants cleared2026: 24 descendants clearedK974468 · Photonic Stimulator · Bales Scientific, Inc. · 1998K032229 · Quantum Warp 10 Light Delivery System · Quantum Devices, Inc. · 20031995200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 3 other ancestors 1 generation forward: 10 descendants2 generations forward: 18 descendants3 generations forward: 23 descendants4 generations forward: 35 descendants5 generations forward: 44 descendants6 generations forward: 33 descendants7 generations forward: 7 descendants8 generations forward: 1 descendant 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 deviceK043317 Omnilux PlusPhoto Therapeutics Limited · 2005
  4. Descendant · cites it directly · 160 of its ownK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
  5. Descendant · cites it directly · 115 of its ownK060792 IllumimedPhotoactif, LLC · 2006
  6. Descendant · cites it directly · 91 of its ownK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
  7. Descendant · cites it directly · 91 of its ownK072459 Omnilux New-UPhoto Therapeutics, Inc. · 2008
  8. Descendant · 2 generations on · 76 of its ownK111286 Quasar CalypsoSilver Bay, LLC · 2012

Showing 5 of 171 descendants. See all descendants

Descendants cleared per year

2005: 12006: 12008: 32009: 22010: 62011: 22012: 32013: 52014: 32015: 42016: 32017: 82018: 42019: 32020: 52021: 102022: 102023: 132024: 172025: 442026: 24
2005high 44 (2025) · low 0 (2007)2026

Most influential descendants

Showing 5 of 171 · See all
  • K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005 · cites it directly160descendants
  • K060792IllumimedPhotoactif, LLC · 2006 · cites it directly115descendants
  • K083183Aklarus Phototherapy SystemHill Laboratories Co. · 2009 · cites it directly91descendants
  • K072459Omnilux New-UPhoto Therapeutics, Inc. · 2008 · cites it directly91descendants
  • K111286Quasar CalypsoSilver Bay, LLC · 2012 · 2 generations on76descendants
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)K043317Omnilux PlusPhoto Therapeutics Limited2005—
+1K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005—
+1K060792IllumimedPhotoactif, LLC2006—
+1K083183Aklarus Phototherapy SystemHill Laboratories Co.2009—
+1K072459Omnilux New-UPhoto Therapeutics, Inc.2008—
+2K111286Quasar CalypsoSilver Bay, LLC2012—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199810
200010
200210

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200510
200610
200830
200920
201060
201120
201230
201350
201430
201540
201630
201780
201840
201930
202050
2021100
2022100
2023130
2024170
2025440
2026240
FIG. 1 — Lineage of K043317, 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? (5)

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
*K974468Photonic Stimulator
Summary page 1
…device: The Omnilux Plus is substantially equivalent to the following Photonic Stimulator manufactured by Bales Scientific Inc (K974468) Quantum Warp 10 manufactured by Quantum Devices Inc (K032229) SuperNova manufactured by Light Force Therapy In…
Bales Scientific, Inc.1998—
*K032229Quantum Warp 10 Light Delivery System
Summary page 1
…ly equivalent to the following Photonic Stimulator manufactured by Bales Scientific Inc (K974468) Quantum Warp 10 manufactured by Quantum Devices Inc (K032229) SuperNova manufactured by Light Force Therapy Inc (K022888) Pain-X-200 0 manufactured by DioMedics Inc (K09825…
Quantum Devices, Inc.2003—
*K022888Acubeam, Super Nova, Dio
Summary page 1
…ured by Bales Scientific Inc (K974468) Quantum Warp 10 manufactured by Quantum Devices Inc (K032229) SuperNova manufactured by Light Force Therapy Inc (K022888) Pain-X-200 0 manufactured by DioMedics Inc (K0982546)…
Light Force Therapy, Inc.2002—
*K982546Phaser-2000
Summary page 1
…manufactured by Quantum Devices Inc (K032229) SuperNova manufactured by Light Force Therapy Inc (K022888) Pain-X-200 0 manufactured by DioMedics Inc (K0982546) & 5) LightPatch/Spinal Pad manufactured by Biosc…
Diomedics, Inc.1998—
*K993684Spinal Pad
Summary page 1
…tured by DioMedics Inc (K0982546) & 5) LightPatch/Spinal Pad manufactured by Bioscan Inc (K993 684 000 01 4 4. Device De…
Bioscan, Inc.2000—

Also cleared against K974468: 3 other devices →

What descends from it? (171)

See all 171

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

NumberDeviceApplicantDecidedDescendants
K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited2005160
K060792IllumimedPhotoactif, LLC2006115
K083183Aklarus Phototherapy SystemHill Laboratories Co.200991
K072459Omnilux New-UPhoto Therapeutics, Inc.200891
K120460SmartluxMedmix Co., Ltd.201218
K082586Lightwave Professional DeluxeLightwave Technologies, LLC20104
K162851eLyx-PROIntelligent Sensory Concept SA20170
K113668Healite II SystemLutronic Corporation20120
K073000LumaprobeClareblend, Inc.20080
K073022Clareblend Led Probes Model# 7201-415, 7204-631, 7205-830Clareblend, 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 5 ancestors has a recall.
  • Of its descendants, K050216 (Photo Therapeutics Limited, 2005) has gone furthest, with 160 descendants of its own.
  • 3 other devices also cite its predicate K974468.

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 Omnilux Plus is used for the temporary relief of minor muscle and joint pain, arthritis and muscle spasm; relieving stiffness; promoting the relaxation of muscle tissue and to temporarily increase local blood circulation where applied.

Indications for use as stated in the FDA summary.

Also cleared against K974468

3 other devices cite the same predicate.

  • K033986MLT-1000 IR Laser SystemMedical Laser Therapeutics LP · 2004
  • K032787Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies · 2003
  • K032229Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003

More from Photo Therapeutics Limited

5 FDA decisions under this applicant name. See the company

  • K050216Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
  • K043329Omnilux Revive and BluePhoto Therapeutics Limited · 2005
  • K030426Omnilux RedPhoto Therapeutics Limited · 2003
  • K030883Omnilux BluePhoto Therapeutics Limited · 2003

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/K043317 · printed Nov 5, 2026

Cite this page

510(k) Report. “K043317: Omnilux Plus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043317

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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