510(k) · Cleared
ClearedLightwave Infrared Lamps LW10D and LW30D
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Skytech Enterprises, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Dec 3, 2003 as substantially equivalent to K020851 (C&H International, 2002) and 1 other predicate after a 362-day review. Its family tree reaches back 2 generations to 1988. 1 later device descends from it.
- Decided
- Dec 3, 2003
- Review
- 362 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K875052 (1988). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK875052 TDP, Lark Brand and Mit LampI.E.C. Co. · 1988
- 1 generation backK020851 TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B…C&H International · 2002
- This deviceK024027 Lightwave Infrared Lamps LW10D and LW30DSkytech Enterprises, Inc. · 2003
- Descendant · cites it directly · 0 of its ownK051046 Painacea Model XR8 Infrared Heat LampAtlantis Luminescent Products, LLC · 2005 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K051046Painacea Model XR8 Infrared Heat LampAtlantis Luminescent Products, LLC · 2005 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K875052 | TDP, Lark Brand and Mit Lamp | I.E.C. Co. | 1988 | — |
| −1 | K020851 | TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B… | C&H International | 2002 | — |
| 0 (this device) | K024027 | Lightwave Infrared Lamps LW10D and LW30D | Skytech Enterprises, Inc. | 2003 | — |
| +1 | K051046 | Painacea Model XR8 Infrared Heat Lamp | Atlantis Luminescent Products, LLC | 2005 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 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? (2)
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 |
|---|---|---|---|
| * | K020851 | TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B…Summary page 2…Infrared Photon Stimulator, Models, LWIOD and LW30D Common Name: Infrared Lamp Classification: 890.5500, 89 ILY, Class II SE Predicates: a) C&H International K02085 1, Infrared Heating Lamp TDP Heat Lamp b) BioScan, Inc. K993684, Infrared Lamp Spinal Pad Device Description:… | 2002 |
| * | K993684 | Spinal PadSummary page 2…p Classification: 890.5500, 89 ILY, Class II SE Predicates: a) C&H International K02085 1, Infrared Heating Lamp TDP Heat Lamp b) BioScan, Inc. K993684, Infrared Lamp Spinal Pad Device Description: The devices are a family (models) of infrared lamps having the same indicati… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K051046 | Painacea Model XR8 Infrared Heat Lamp | 2005 | 0 |
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 15 years and passes through 3 companies; a new generation was cleared every 14.3 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K051046 (Atlantis Luminescent Products, LLC, 2005) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K020851.
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?
To provide infrared Jight energy that penetrates the skin to promote increased blood flow and circulation, thereby, providing temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, and muscle spasm. The elevated tissue temperature also promotes relaxation of muscles and relief from pain resulting in improved range of motion.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K024027 · printed Nov 5, 2026
Cite this page
510(k) Report. “K024027: Lightwave Infrared Lamps LW10D and LW30D.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K024027
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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