510(k) · Cleared
ClearedMaestro MDTL Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Medical Technologies, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Feb 3, 2006 as substantially equivalent to K001179 (Light Force Therapy, Inc., 2000) and 4 other predicates after a 51-day review. Its family tree reaches back 5 generations to 1988. 8 later devices descend from it.
- Decided
- Feb 3, 2006
- Review
- 51 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K875052 (1988). 17 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK875052 TDP, Lark Brand and Mit LampI.E.C. Co. · 1988
- 4 generations backK020851 TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B…C&H International · 2002
- 3 generations backK024179 Palomar LightcubePalomar Medical Products, Inc. · 2003
- 2 generations backK032787 Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies · 2003
- 1 generation backK033986 MLT-1000 IR Laser SystemMedical Laser Therapeutics LP · 2004
- This deviceK053473 Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc. · 2006
- Descendant · cites it directly · 5 of its ownK061656 Laser-D68Laser Pain Clinics LP · 2006
- Descendant · 2 generations on · 4 of its ownK120604 K-LaserEltech S.R.L · 2012
- Descendant · cites it directly · 1 of its ownK082969 Luminex Infrared Lamp SystemMedical Laser Systems, Inc. · 2008
- Descendant · 3 generations on · 0 of its ownK171087 AXON IR Heat LampCrystal Medtech, LLC · 2017
- Descendant · 3 generations on · 0 of its ownK161198 Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K061656Laser-D68Laser Pain Clinics LP · 2006 · cites it directly5descendants
- K120604K-LaserEltech S.R.L · 2012 · 2 generations on4descendants
- K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc. · 2008 · cites it directly1descendant
- K171087AXON IR Heat LampCrystal Medtech, LLC · 2017 · 3 generations on0descendants
- K161198Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3Usa Laser Biotech, Inc. · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K875052 | TDP, Lark Brand and Mit Lamp | I.E.C. Co. | 1988 | — |
| −4 | K020851 | TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B… | C&H International | 2002 | — |
| −3 | K024179 | Palomar Lightcube | Palomar Medical Products, Inc. | 2003 | — |
| −2 | K032787 | Neurolase, Models 150V, 150C, 1064 | Spectrum Laser & Technologies | 2003 | — |
| −1 | K033986 | MLT-1000 IR Laser System | Medical Laser Therapeutics LP | 2004 | — |
| 0 (this device) | K053473 | Maestro MDTL Laser System | Advanced Medical Technologies, Inc. | 2006 | — |
| +1 | K061656 | Laser-D68 | Laser Pain Clinics LP | 2006 | — |
| +2 | K120604 | K-Laser | Eltech S.R.L | 2012 | — |
| +1 | K082969 | Luminex Infrared Lamp System | Medical Laser Systems, Inc. | 2008 | — |
| +3 | K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | 2017 | — |
| +3 | K161198 | Lumix Ultra 1, Lumix Ultra 2, Lumix Ultra 3 | Usa Laser Biotech, Inc. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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? (5)
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 |
|---|---|---|---|
| * | K001179 | Super Nova, AcubeamSummary page 2…sentative predicate devices to the Maestro MDTL Laser System include, but are not limited to, the Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), Medical Laser Therapeutics, LP MLT-1000 IR Laser System (K033986), the Meditech International Inc BioFlex Profess… | 2000 |
| * | K033986 | MLT-1000 IR Laser SystemSummary page 2…e, but are not limited to, the Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), Medical Laser Therapeutics, LP MLT-1000 IR Laser System (K033986), the Meditech International Inc BioFlex Professional Therapy System (K023621), the Thor International DDII Laser S… | 2004 |
| * | K023621 | Bioflex Professional Therapy SystemSummary page 2…m Systems (K001179), Medical Laser Therapeutics, LP MLT-1000 IR Laser System (K033986), the Meditech International Inc BioFlex Professional Therapy System (K023621), the Thor International DDII Laser System (K033923) and the Chattanooga Group Vectra Genisys Laser System (K040662… | 2003 |
| * | K033923 | TH0R Ddii IR Lamp SystemSummary page 2…MLT-1000 IR Laser System (K033986), the Meditech International Inc BioFlex Professional Therapy System (K023621), the Thor International DDII Laser System (K033923) and the Chattanooga Group Vectra Genisys Laser System (K040662). V. Summary of the Technical Characteristics of the… | 2004 |
| * | K040662 | Vectra Genisys (Module & Transportable) and Intelect XT (Module & Transportable) Laser…Summary page 2…nc BioFlex Professional Therapy System (K023621), the Thor International DDII Laser System (K033923) and the Chattanooga Group Vectra Genisys Laser System (K040662). V. Summary of the Technical Characteristics of the Maestro MDTL Laser System as Related to the Referenced Predicate… | 2004 |
What descends from it? (8)
2 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 18 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- None of the 17 ancestors has a recall.
- Of its descendants, K061656 (Laser Pain Clinics LP, 2006) has gone furthest, with 5 descendants of its own.
- 12 other devices also cite its predicate K001179.
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?
The Maestro MDTL Laser System is intended to emit energy in the visible red & infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasm; the temporary increase in local blood circulation; and / or the temporary relaxation of muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K053473 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053473: Maestro MDTL Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K053473
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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