510(k) · Cleared
Recalled · 2006Lumiwave 1X4 Infrared Therapy Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocare Systems, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Aug 26, 2005 as substantially equivalent to K042532 (Biocare Systems, Inc., 2004) after a 52-day review. Its family tree reaches back 3 generations to 1998. 3 later devices descend from it. It has been recalled once.
- Decided
- Aug 26, 2005
- Review
- 52 days
- Class
- Class II
- Product code
- ILY
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K974468 (1998). 6 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK974468 Photonic StimulatorBales Scientific, Inc. · 1998
- 2 generations backK032229 Quantum Warp 10 Light Delivery SystemQuantum Devices, Inc. · 2003
- 1 generation backK042532 Biocare Systems Premir 818Biocare Systems, Inc. · 2004
- This deviceK051816 Lumiwave 1X4 Infrared Therapy DeviceBiocare Systems, Inc. · 2005
- Descendant · cites it directly · 0 of its ownK170068 Softcure 96Wellray Medical Laser, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK142256 Applied BioPhotonics Phototherapy System ABPT1003Applied Biophotonics, Ltd. · 2015
- Descendant · cites it directly · 0 of its ownK073681 Nanobeam 940, Model 940-900-02Davaray, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K974468 | Photonic Stimulator | Bales Scientific, Inc. | 1998 | — |
| −2 | K032229 | Quantum Warp 10 Light Delivery System | Quantum Devices, Inc. | 2003 | — |
| −1 | K042532 | Biocare Systems Premir 818 | Biocare Systems, Inc. | 2004 | — |
| 0 (this device) | K051816 | Lumiwave 1X4 Infrared Therapy Device | Biocare Systems, Inc. | 2005 | — |
| +1 | K170068 | Softcure 96 | Wellray Medical Laser, Inc. | 2017 | — |
| +1 | K142256 | Applied BioPhotonics Phototherapy System ABPT1003 | Applied Biophotonics, Ltd. | 2015 | — |
| +1 | K073681 | Nanobeam 940, Model 940-900-02 | Davaray, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
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 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? (1)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042532 | Biocare Systems Premir 818Summary page 1…1X4 Infrared Therapy Device Classification name: Infrared Lamp MODIFIED FROM DEVICE: Trade name: BioCare System's PremIR 818 510(k) number: K042532 DEVICE DESCRIPTION The LumiWave 1X4 Infrared Therapy Device is an over-the-counter, infrared-therapy device, designed to emit… | 2004 |
What descends from it? (3)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 14, 2006 | Not classified | Z-1419-06 | Other | Electrical Safety Hazard-when pulling on the cord of the AC adapter, to remove it from an outlet, the prongs on the AC adapter, may detach from the unit, damaging it and exposing the user to an electrical safety hazard |
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 1.3 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K170068 (Wellray Medical Laser, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K042532.
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?
BioCare system's infrared therapy products emit energy in the infrared spectrum for the purposes of elevating tissue temperature; for temporary relief/ reduction of minor muscular pain, minor muscular back pain and minor joint pain and stiffness. Additionally, these products are intended to provide a temporary increase in local blood circulation and provide temporary relief of muscle spasms and minor sub-acute or chronic pain associated with arthritis, sprains or strains.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051816 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051816: Lumiwave 1X4 Infrared Therapy Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051816
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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