510(k) · Cleared
ClearedKenkowave Infrared Pain Treatment System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Kaylight Corporation · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Mar 2, 2004 after a 111-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Mar 2, 2004
- Review
- 111 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
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?
No later submission names this one as a predicate yet.
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.
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 KenkoWave Infrared Treatment System is a non-invasive, portable, home use device intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, minor arthritis pain, muscle spasm, relieving stiffness and promoting relaxation of the muscle tissue.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K033555 · printed Nov 3, 2026
Cite this page
510(k) Report. “K033555: Kenkowave Infrared Pain Treatment System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K033555
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026