510(k) · Cleared
ClearedK-Laser K-1200, Model 12 W
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 Aug 19, 2009 as substantially equivalent to K050070 (Eltech S.R.L, 2005) and 1 other predicate after a 91-day review. Its family tree reaches back 6 generations to 2000. 7 later devices descend from it.
- Decided
- Aug 19, 2009
- Review
- 91 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to K001179 (2000). 13 ancestors in all, the oldest K941461 (1995). 7 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 5 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 4 generations backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- 3 generations backK040729 Solaris D890 Therapy ProbeDynatronics Corp. · 2004
- 2 generations backK050070 K-Laser, Models 3,4,4D,6DEltech S.R.L · 2005
- 1 generation backK070400 LC Therapy, Model LCT-1000Litecure, LLC · 2007
- This deviceK091497 K-Laser K-1200, Model 12 WEltech S.R.L · 2009
- Descendant · cites it directly · 4 of its ownK120604 K-LaserEltech S.R.L · 2012
- Descendant · 2 generations on · 0 of its ownK171087 AXON IR Heat LampCrystal Medtech, LLC · 2017
- Descendant · 2 generations on · 0 of its ownK161198 Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016
- Descendant · 2 generations on · 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 · 2 generations on · 0 of its ownK151521 Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC · 2015
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K120604K-LaserEltech S.R.L · 2012 · cites it directly4descendants
- K171087AXON IR Heat LampCrystal Medtech, LLC · 2017 · 2 generations on0descendants
- K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016 · 2 generations on0descendants
- K160947LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp System LUMIX…Usa Laser Biotech, Inc. · 2016 · 2 generations on0descendants
- K151521Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −5 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −4 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| −3 | K040729 | Solaris D890 Therapy Probe | Dynatronics Corp. | 2004 | — |
| −2 | K050070 | K-Laser, Models 3,4,4D,6D | Eltech S.R.L | 2005 | — |
| −1 | K070400 | LC Therapy, Model LCT-1000 | Litecure, LLC | 2007 | — |
| 0 (this device) | K091497 | K-Laser K-1200, Model 12 W | Eltech S.R.L | 2009 | — |
| +1 | K120604 | K-Laser | Eltech S.R.L | 2012 | — |
| +2 | K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | 2017 | — |
| +2 | K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | 2016 | — |
| +2 | K160947 | LUMIX CPS 1 IR Lamp System LUMIX CPS 2 IR Lamp System LUMIX CPS 3 IR Lamp… | Usa Laser Biotech, Inc. | 2016 | — |
| +2 | K151521 | Phoenix Thera-Lase System | Phoenix Thera-Lase Systems, LLC | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 4 | 0 |
| 2000 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K050070 | K-Laser, Models 3,4,4D,6DSummary page 2…5 Page 2 of 3 2. PREDICATE DEVICES: K-LASER - Cleared under K050070 LCT-1000 - Cleared under K070400 3. PERFORMANCE STANDARDS: K-1200 conforms to the applicable requirements of 21 CFR… | 2005 |
| * | K070400 | LC Therapy, Model LCT-1000Summary page 2…Page 2 of 3 2. PREDICATE DEVICES: K-LASER - Cleared under K050070 LCT-1000 - Cleared under K070400 3. PERFORMANCE STANDARDS: K-1200 conforms to the applicable requirements of 21 CFR section 1010 (Performance Standar… | 2007 |
What descends from it? (7)
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)
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 9 years and passes through 5 companies; a new generation was cleared every 1.7 years on median.
- None of the 13 ancestors has a recall.
- Of its descendants, K120604 (Eltech S.R.L, 2012) has gone furthest, with 4 descendants of its own.
- 4 other devices also cite its predicate K050070.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The 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/K091497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091497: K-Laser K-1200, Model 12 W.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091497
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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