510(k) · Cleared
ClearedNeurolase, Models 150V, 150C, 1064
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spectrum Laser & Technologies · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Nov 20, 2003 as substantially equivalent to K001179 (Light Force Therapy, Inc., 2000) and 4 other predicates after a 73-day review. Its family tree reaches back 3 generations to 1988. 15 later devices descend from it.
- Decided
- Nov 20, 2003
- Review
- 73 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 3 generations to K875052 (1988). 12 ancestors in all. 15 later devices descend from it, 4 citing it directly.
- Root · 3 generations backK875052 TDP, Lark Brand and Mit LampI.E.C. Co. · 1988
- 2 generations backK020851 TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B…C&H International · 2002
- 1 generation backK024179 Palomar LightcubePalomar Medical Products, Inc. · 2003
- This deviceK032787 Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies · 2003
- Descendant · cites it directly · 10 of its ownK033986 MLT-1000 IR Laser SystemMedical Laser Therapeutics LP · 2004
- Descendant · 2 generations on · 8 of its ownK053473 Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc. · 2006
- Descendant · 3 generations on · 5 of its ownK061656 Laser-D68Laser Pain Clinics LP · 2006
- Descendant · 4 generations on · 4 of its ownK120604 K-LaserEltech S.R.L · 2012
- Descendant · 3 generations on · 1 of its ownK082969 Luminex Infrared Lamp SystemMedical Laser Systems, Inc. · 2008
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K033986MLT-1000 IR Laser SystemMedical Laser Therapeutics LP · 2004 · cites it directly10descendants
- K053473Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc. · 2006 · 2 generations on8descendants
- K061656Laser-D68Laser Pain Clinics LP · 2006 · 3 generations on5descendants
- K120604K-LaserEltech S.R.L · 2012 · 4 generations on4descendants
- K082969Luminex Infrared Lamp SystemMedical Laser Systems, Inc. · 2008 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K875052 | TDP, Lark Brand and Mit Lamp | I.E.C. Co. | 1988 | — |
| −2 | K020851 | TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B… | C&H International | 2002 | — |
| −1 | K024179 | Palomar Lightcube | Palomar Medical Products, Inc. | 2003 | — |
| 0 (this device) | K032787 | Neurolase, Models 150V, 150C, 1064 | Spectrum Laser & Technologies | 2003 | — |
| +1 | K033986 | MLT-1000 IR Laser System | Medical Laser Therapeutics LP | 2004 | — |
| +2 | K053473 | Maestro MDTL Laser System | Advanced Medical Technologies, Inc. | 2006 | — |
| +3 | K061656 | Laser-D68 | Laser Pain Clinics LP | 2006 | — |
| +4 | K120604 | K-Laser | Eltech S.R.L | 2012 | — |
| +3 | K082969 | Luminex Infrared Lamp System | Medical Laser Systems, Inc. | 2008 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 3 | 0 |
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 2 | 0 |
| 2016 | 2 | 0 |
| 2017 | 1 | 0 |
| 2022 | 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, Acubeam | 2000 |
| * | K020017 | Medx 1000 Series | 2002 |
| * | K974468 | Photonic StimulatorSummary page 1…eam systems (KO01 179) manufactured by Light ForceTherapy, Inc., the Medx 1000 Series devices (KO20017) manufactured by Medx Health Corporation, the Photonic Stimulator (K974468) manufactured by Bales Scientific, the SLP 1000 Themapulse (KO24179) manufactured by Palomar, the Pain-X 2000 (K982546) manufactu… | 1998 |
| * | K024179 | Palomar Lightcube | 2003 |
| * | K982546 | Phaser-2000Summary page 1…Medx Health Corporation, the Photonic Stimulator (K974468) manufactured by Bales Scientific, the SLP 1000 Themapulse (KO24179) manufactured by Palomar, the Pain-X 2000 (K982546) manufactured by Diomedics, and the SLP 1000 Themapulse (KO24179) manufactured by Palomar. 4. Intended Use of the Device The Ne… | 1998 |
What descends from it? (15)
See all 154 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 15 years and passes through 4 companies; a new generation was cleared every 8 months on median.
- None of the 12 ancestors has a recall.
- Of its descendants, K033986 (Medical Laser Therapeutics LP, 2004) has gone furthest, with 10 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 Neurolase devices are an infrared lamp per 21 CFR 890.5500 that emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature to provide temporary relief of minor muscles and joint pain and stiffness, minor pain and stiffness associated with arthritis, or muscle spasm. These devices may temporarily increase blood circulation, and may be used to promote relaxation of muscle tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032787 · printed Nov 5, 2026
Cite this page
510(k) Report. “K032787: Neurolase, Models 150V, 150C, 1064.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K032787
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