510(k) · Cleared
ClearedGallieon-1 Medical Laser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Future Device and Technology, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on May 12, 2014 as substantially equivalent to K031612 (Avicenna Laser Technology, Inc., 2003) and 2 other predicates after a 273-day review. Its family tree reaches back 6 generations to 2000.
- Decided
- May 12, 2014
- Review
- 273 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K001179 (2000). 13 ancestors in all, the oldest K941461 (1995). No later device cites it as a predicate yet.
- 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 backK083560 Expanded Spectrum Photo Therapy Device, Model Espt-3XLighthouse Technical Innovations, Inc. · 2008
- This deviceK132529 Gallieon-1 Medical LaserFuture Device and Technology, Inc. · 2014
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 | K083560 | Expanded Spectrum Photo Therapy Device, Model Espt-3X | Lighthouse Technical Innovations, Inc. | 2008 | — |
| 0 (this device) | K132529 | Gallieon-1 Medical Laser | Future Device and Technology, Inc. | 2014 | — |
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 |
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? (3)
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 |
|---|---|---|---|
| * | K031612 | Alt Laser, Model VTR 75Summary page 1…3. Predicate Devices The Gallieon-1 is equivalent to the following devices: 510(k) number Device Manufacturer K031612 ALT Laser, Model VTR 75 Avicenna Laser Technology, Inc. K050070 Klaser Therapy Probe… | 2003 |
| * | K050070 | K-Laser, Models 3,4,4D,6DSummary page 1…mber Device Manufacturer K031612 ALT Laser, Model VTR 75 Avicenna Laser Technology, Inc. K050070 Klaser Therapy Probe Eltech, S.R.L K083560 ESPT-3X… | 2005 |
| * | K083560 | Expanded Spectrum Photo Therapy Device, Model Espt-3XSummary page 1…ALT Laser, Model VTR 75 Avicenna Laser Technology, Inc. K050070 Klaser Therapy Probe Eltech, S.R.L K083560 ESPT-3X Light Technical Innovation, Inc.… | 2008 |
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.
What does this lineage say?
- The line of descent spans 14 years and passes through 6 companies; a new generation was cleared every 1.7 years on median.
- None of the 13 ancestors has a recall.
- 8 other devices also cite its predicate K031612.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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/K132529 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132529: Gallieon-1 Medical Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132529
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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