510(k) · Cleared
ClearedMLT-1000 IR Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medical Laser Therapeutics LP · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Mar 29, 2004 as substantially equivalent to K974468 (Bales Scientific, Inc., 1998) and 3 other predicates after a 97-day review. Its family tree reaches back 4 generations to 1988. 10 later devices descend from it.
- Decided
- Mar 29, 2004
- Review
- 97 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 4 generations to K875052 (1988). 14 ancestors in all. 10 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK875052 TDP, Lark Brand and Mit LampI.E.C. Co. · 1988
- 3 generations backK020851 TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B…C&H International · 2002
- 2 generations backK024179 Palomar LightcubePalomar Medical Products, Inc. · 2003
- 1 generation backK032787 Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies · 2003
- This deviceK033986 MLT-1000 IR Laser SystemMedical Laser Therapeutics LP · 2004
- Descendant · cites it directly · 8 of its ownK053473 Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc. · 2006
- Descendant · 2 generations on · 5 of its ownK061656 Laser-D68Laser Pain Clinics LP · 2006
- Descendant · 3 generations on · 4 of its ownK120604 K-LaserEltech S.R.L · 2012
- Descendant · 2 generations on · 1 of its ownK082969 Luminex Infrared Lamp SystemMedical Laser Systems, Inc. · 2008
- Descendant · 4 generations on · 0 of its ownK171087 AXON IR Heat LampCrystal Medtech, LLC · 2017
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K053473Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc. · 2006 · cites it directly8descendants
- K061656Laser-D68Laser Pain Clinics LP · 2006 · 2 generations on5descendants
- K120604K-LaserEltech S.R.L · 2012 · 3 generations on4descendants
- K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc. · 2008 · 2 generations on1descendant
- K171087AXON IR Heat LampCrystal Medtech, LLC · 2017 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K875052 | TDP, Lark Brand and Mit Lamp | I.E.C. Co. | 1988 | — |
| −3 | K020851 | TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B… | C&H International | 2002 | — |
| −2 | K024179 | Palomar Lightcube | Palomar Medical Products, Inc. | 2003 | — |
| −1 | K032787 | Neurolase, Models 150V, 150C, 1064 | Spectrum Laser & Technologies | 2003 | — |
| 0 (this device) | K033986 | MLT-1000 IR Laser System | Medical Laser Therapeutics LP | 2004 | — |
| +1 | K053473 | Maestro MDTL Laser System | Advanced Medical Technologies, Inc. | 2006 | — |
| +2 | K061656 | Laser-D68 | Laser Pain Clinics LP | 2006 | — |
| +3 | K120604 | K-Laser | Eltech S.R.L | 2012 | — |
| +2 | K082969 | Luminex Infrared Lamp System | Medical Laser Systems, Inc. | 2008 | — |
| +4 | K171087 | AXON IR Heat Lamp | Crystal Medtech, LLC | 2017 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 2 | 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? (4)
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 |
|---|---|---|---|
| * | K974468 | Photonic StimulatorSummary page 1…that are currently in commercial distribution. These predicate devices include, but are not limited to, the Bales Scientific, Inc. Photonic Stimulator (K974468), Light Force Therapy, Inc. Super Nova and Acubeam Systems (KO01 179), the Meditech International Inc BioFlex P… | 1998 |
| * | K001179 | Super Nova, Acubeam | 2000 |
| * | K023621 | Bioflex Professional Therapy SystemSummary page 1…tor (K974468), Light Force Therapy, Inc. Super Nova and Acubeam Systems (KO01 179), the Meditech International Inc BioFlex Professional Therapy System (K023621) and the Spectrum Laser & Technologies, Inc. Neurolase Series (K032787). 510(k) Premarket Notification MLT-1000 IR La… | 2003 |
| * | K032787 | Neurolase, Models 150V, 150C, 1064Summary page 1…(KO01 179), the Meditech International Inc BioFlex Professional Therapy System (K023621) and the Spectrum Laser & Technologies, Inc. Neurolase Series (K032787). 510(k) Premarket Notification MLT-1000 IR Laser System Page 14 of 18 December 22, 2003… | 2003 |
What descends from it? (10)
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 16 years and passes through 5 companies; a new generation was cleared every 8 months on median.
- None of the 14 ancestors has a recall.
- Of its descendants, K053473 (Advanced Medical Technologies, Inc., 2006) has gone furthest, with 8 descendants of its own.
- 3 other devices also cite its predicate K974468.
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 MLT - 1000 IR Laser System is intended to emit energy in the 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 promoting relaxation of muscle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K033986 · printed Nov 6, 2026
Cite this page
510(k) Report. “K033986: MLT-1000 IR Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K033986
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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