510(k) · Cleared
ClearedPhotonic Stimulator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bales Scientific, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jun 22, 1998 after a 208-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 215 later devices descend from it.
- Decided
- Jun 22, 1998
- Review
- 208 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 0
215 later devices descend from it, 4 citing it directly.
- This deviceK974468 Photonic StimulatorBales Scientific, Inc. · 1998
- Descendant · cites it directly · 198 of its ownK032229 Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003
- Descendant · cites it directly · 171 of its ownK043317 Omnilux PlusPhoto Therapeutics Limited · 2005
- Descendant · 2 generations on · 160 of its ownK050216 Omnilux Revive and Omnilux PlusPhoto Therapeutics Limited · 2005
- Descendant · 2 generations on · 115 of its ownK060792 IllumimedPhotoactif, LLC · 2006
- Descendant · 2 generations on · 91 of its ownK083183 Aklarus Phototherapy SystemHill Laboratories Co. · 2009
Showing 5 of 215 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 215 · 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
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974468 | Photonic Stimulator | Bales Scientific, Inc. | 1998 | — |
| +1 | K032229 | Quantum Warp 10 Light Delivery System | Quantum Devices, Inc. | 2003 | — |
| +1 | K043317 | Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| +2 | K050216 | Omnilux Revive and Omnilux Plus | Photo Therapeutics Limited | 2005 | — |
| +2 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
| +2 | K083183 | Aklarus Phototherapy System | Hill Laboratories Co. | 2009 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 8 | 0 |
| 2006 | 6 | 0 |
| 2007 | 2 | 0 |
| 2008 | 8 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 3 | 0 |
| 2012 | 8 | 0 |
| 2013 | 6 | 0 |
| 2014 | 3 | 0 |
| 2015 | 10 | 0 |
| 2016 | 6 | 0 |
| 2017 | 10 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2020 | 5 | 0 |
| 2021 | 10 | 0 |
| 2022 | 11 | 0 |
| 2023 | 13 | 0 |
| 2024 | 17 | 0 |
| 2025 | 44 | 0 |
| 2026 | 24 | 0 |
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 K242755 Medical Diode Laser Systems (VELAS II-30B…score 18.7 · 22 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (215)
See all 2154 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ILY
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ILY
116in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ILY
1in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILY
17in 2025
MAUDE reports naming product code ILY, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 10 | 128 | 0 | 24 |
| 2008 | 16 | 165 | 0 | 20 |
| 2009 | 13 | 189 | 0 | 9 |
| 2010 | 8 | 185 | 1 | 7 |
| 2011 | 9 | 198 | 0 | 10 |
| 2012 | 11 | 130 | 3 | 7 |
| 2013 | 9 | 211 | 0 | 8 |
| 2014 | 11 | 153 | 0 | 0 |
| 2015 | 11 | 146 | 0 | 2 |
| 2016 | 8 | 214 | 0 | 2 |
| 2017 | 5 | 116 | 0 | 12 |
| 2018 | 0 | — | 0 | 1 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 5 |
| 2022 | 2 | — | 4 | 2 |
| 2023 | 1 | — | 1 | 15 |
| 2024 | 1 | — | 0 | 19 |
| 2025 | 1 | — | 1 | 17 |
| 2026 | 1 | — | 1 | — |
What is it indicated for?
The Photonic Stimulator emits infrared light that penetrates the skin to promote increased blood flow and circulation, thereby providing safe, temporary relief of minor aches and pains where heat is indicated.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974468 · printed Nov 6, 2026
Cite this page
510(k) Report. “K974468: Photonic Stimulator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K974468
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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