510(k) · Cleared
ClearedStimlase 2000 Low Level Laser Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Laserstim, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jul 3, 2013 as substantially equivalent to K082969 (Medical Laser Systems, Inc., 2008) and 1 other predicate after a 267-day review. Its family tree reaches back 7 generations to 1988.
- Decided
- Jul 3, 2013
- Review
- 267 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K875052 (1988). 29 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK875052 TDP, Lark Brand and Mit LampI.E.C. Co. · 1988
- 6 generations backK020851 TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B…C&H International · 2002
- 5 generations backK024179 Palomar LightcubePalomar Medical Products, Inc. · 2003
- 4 generations backK032787 Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies · 2003
- 3 generations backK033986 MLT-1000 IR Laser SystemMedical Laser Therapeutics LP · 2004
- 2 generations backK053473 Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc. · 2006
- 1 generation backK082969 Luminex Infrared Lamp SystemMedical Laser Systems, Inc. · 2008
- This deviceK123177 Stimlase 2000 Low Level Laser Therapy SystemLaserstim, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K875052 | TDP, Lark Brand and Mit Lamp | I.E.C. Co. | 1988 | — |
| −6 | K020851 | TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B… | C&H International | 2002 | — |
| −5 | K024179 | Palomar Lightcube | Palomar Medical Products, Inc. | 2003 | — |
| −4 | K032787 | Neurolase, Models 150V, 150C, 1064 | Spectrum Laser & Technologies | 2003 | — |
| −3 | K033986 | MLT-1000 IR Laser System | Medical Laser Therapeutics LP | 2004 | — |
| −2 | K053473 | Maestro MDTL Laser System | Advanced Medical Technologies, Inc. | 2006 | — |
| −1 | K082969 | Luminex Infrared Lamp System | Medical Laser Systems, Inc. | 2008 | — |
| 0 (this device) | K123177 | Stimlase 2000 Low Level Laser Therapy System | Laserstim, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 4 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K082969 | Luminex Infrared Lamp SystemSummary page 3…= Page 3 === Substantial Equivalence: The StimL-ase 2000 System therapeutic heating feature is substantially equivalent to the Luminex Infrared Lamp System (K082969) and the Mettler Sys*Stim 240, ME 240 Combination Neuromuscular Stimulator and Low Level Light Therapy device (Ki 130… | 2008 |
| * | K113017 | Sys*Stim 240 | 2012 |
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 25 years and passes through 8 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 29 ancestors has a recall of any class.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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 StimLase 2000 System is intended to be used for topical heating of tissue for the purpose of temporary relief of minor muscle and joint pain and stiffness, minor arthritis pain, or muscle spasms. The unit may be used for temporary increase in local blood circulation and/or the temporary relaxation of muscles.
The StimLase 2000 System is intended to be used for relaxation of muscle spasms, prevention or retardation of disuse atrophy, increasing local blood circulation, muscle re-education, maintaining or increasing range of motion, and immediate post-surgical stimulation of calf muscles to prevent venous thrombosis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123177: Stimlase 2000 Low Level Laser Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123177
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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