510(k) Report

510(k) · Cleared

Cleared

Acubeam, Super Nova, Dio

K022888510(k) TraditionalCleared Dec 11, 2002103-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

Light Force Therapy, Inc. · ILY Lamp, Infrared, Therapeutic Heating

Cleared on Dec 11, 2002 after a 103-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 201 later devices descend from it.

Decided
Dec 11, 2002
Review
103 days
Class
Class II
Product code
ILY
Recalls
None
Predicates
0

201 later devices descend from it, 8 citing it directly.

Descendants, by year cleared 2004: 2 descendants cleared2005: 7 descendants cleared2007: 2 descendants cleared2003: 1 descendant cleared2006: 4 descendants cleared2009: 4 descendants cleared2011: 3 descendants cleared2012: 7 descendants cleared2008: 6 descendants cleared2017: 9 descendants cleared2010: 6 descendants cleared2015: 8 descendants cleared2016: 4 descendants cleared2013: 5 descendants cleared2019: 3 descendants cleared2025: 44 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 cleared200020052010201520202025
  1. This deviceK022888 Acubeam, Super Nova, DioLight Force Therapy, Inc. · 2002
  2. Descendant · cites it directly · 198 of its ownK032229 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

Showing 5 of 201 descendants. See all descendants

Descendants cleared per year

2003: 12004: 22005: 72006: 42007: 22008: 62009: 42010: 62011: 32012: 72013: 52014: 32015: 82016: 42017: 92018: 42019: 32020: 52021: 102022: 102023: 132024: 172025: 442026: 24
2003high 44 (2025) · low 1 (2003)2026

Most influential descendants

Showing 5 of 201 · See all
  • K032229Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003 · cites it directly198descendants
  • 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
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K022888Acubeam, Super Nova, DioLight Force Therapy, Inc.2002—
+1K032229Quantum 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—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200310
200420
200570
200640
200720
200860
200940
201060
201130
201270
201350
201430
201580
201640
201790
201840
201930
202050
2021100
2022100
2023130
2024170
2025440
2026240
FIG. 1 — Lineage of K022888, 2002–2026Source: 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 510(k) statement (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?

FDA’s file for it is a 510(k) statement, which names no predicate.

What descends from it? (201)

See all 201

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

NumberDeviceApplicantDecidedDescendants
K032229Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc.2003198
K043317Omnilux PlusPhoto Therapeutics Limited2005171
K042813Biobeam Narrow Band Light Therapy DevicesLife Without Pain, LLC200522
K083580Anti-Wrinkle Light, Model 1302 and Pain Therapy Light, Model 1301Led Intellectual Properties, LLC200915
K042532Biocare Systems Premir 818Biocare Systems, Inc.20048
K070690The Life VesselCottonwood Vessel Corporation20070
K052492Airnergy+StreamNatural Energy Solutions AG20060
K041364ML830 Laser SystemMicrolight Corporation of America20040

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?

  • Of its descendants, K032229 (Quantum Devices, Inc., 2003) has gone furthest, with 198 descendants of its own.

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 Light-Force-Therapy line of infrared lamps are indicated for use to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature, 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 as stated in the FDA 510(k) statement.

Cite this page

510(k) Report. “K022888: Acubeam, Super Nova, Dio.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K022888

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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