510(k) · Cleared
ClearedK-Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Eltech S.R.L · ILY Lamp, Infrared, Therapeutic Heating
Cleared on May 25, 2012 as substantially equivalent to K091497 (Eltech S.R.L, 2009) and 1 other predicate after an 87-day review. Its family tree reaches back 7 generations to 1988. 4 later devices descend from it.
- Decided
- May 25, 2012
- Review
- 87 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K875052 (1988). 30 ancestors in all. 4 later devices descend from it, 4 citing it directly.
- Root · 7 generations backK875052 TDP, Lark Brand and Mit LampI.E.C. Co. · 1988
- 6 generations backK020851 TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B…C&H International · 2002
- 5 generations backK024179 Palomar LightcubePalomar Medical Products, Inc. · 2003
- 4 generations backK032787 Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies · 2003
- 3 generations backK033986 MLT-1000 IR Laser SystemMedical Laser Therapeutics LP · 2004
- 2 generations backK053473 Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc. · 2006
- 1 generation backK061656 Laser-D68Laser Pain Clinics LP · 2006
- This deviceK120604 K-LaserEltech S.R.L · 2012
- Descendant · cites it directly · 0 of its ownK171087 AXON IR Heat LampCrystal Medtech, LLC · 2017
- Descendant · cites it directly · 0 of its ownK161198 Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK160947 LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR…Usa Laser Biotech, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK151521 Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC · 2015
Most influential descendants
Showing 4 of 4 · See all- K171087AXON IR Heat LampCrystal Medtech, LLC · 2017 · cites it directly0descendants
- K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016 · cites it directly0descendants
- K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc. · 2016 · cites it directly0descendants
- K151521Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K875052 | TDP, Lark Brand and Mit Lamp | I.E.C. Co. | 1988 | — |
| −6 | K020851 | TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B… | C&H International | 2002 | — |
| −5 | K024179 | Palomar Lightcube | Palomar Medical Products, Inc. | 2003 | — |
| −4 | K032787 | Neurolase, Models 150V, 150C, 1064 | Spectrum Laser & Technologies | 2003 | — |
| −3 | K033986 | MLT-1000 IR Laser System | Medical Laser Therapeutics LP | 2004 | — |
| −2 | K053473 | Maestro MDTL Laser System | Advanced Medical Technologies, Inc. | 2006 | — |
| −1 | K061656 | Laser-D68 | Laser Pain Clinics LP | 2006 | — |
| 0 (this device) | K120604 | K-Laser | Eltech S.R.L | 2012 | — |
| +1 | K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | 2017 | — |
| +1 | K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | 2016 | — |
| +1 | K160947 | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp… | Usa Laser Biotech, Inc. | 2016 | — |
| +1 | K151521 | Phoenix Thera-Lase System | Phoenix Thera-Lase Systems, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 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? (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 |
|---|---|---|---|
| * | K091497 | K-Laser K-1200, Model 12 WSummary page 2…CATE DEVICES: NC 0 " The device under submission is substantially equivalent to the predicate devices: K091497 (K-1200); K061656 (Laser-068); The device under submission is a family of laser emit a beam of coherent light in ei… | 2009 |
| * | K061656 | Laser-D68Summary page 2…NC 0 " The device under submission is substantially equivalent to the predicate devices: K091497 (K-1200); K061656 (Laser-068); The device under submission is a family of laser emit a beam of coherent light in either continuous wave… | 2006 |
What descends from it? (4)
4 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?
- The line of descent spans 24 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- None of the 30 ancestors has a recall.
- Of its descendants, K171087 (Crystal Medtech, LLC, 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K091497.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
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?
Each device is indicated for emitting energy in the Infrared Spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with arthritis and promoting relaxation of the muscle tissue and to temporarily increase local blood circulation.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K120604 · printed Nov 6, 2026
Cite this page
510(k) Report. “K120604: K-Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K120604
Report an extraction error
Are you the manufacturer?
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