510(k) · Cleared
ClearedCurae'lase CL1000 IR Laser System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Curae'Lase, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Dec 9, 2005 as substantially equivalent to K023621 (Meditech International, Inc., 2003) and 4 other predicates after a 23-day review. Its family tree reaches back 5 generations to 1988.
- Decided
- Dec 9, 2005
- Review
- 23 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 5 generations to K875052 (1988). 21 ancestors in all. No later device cites it as a predicate yet.
- 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 deviceK053201 Curae'lase CL1000 IR Laser SystemCurae'Lase, Inc. · 2005
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) | K053201 | Curae'lase CL1000 IR Laser System | Curae'Lase, Inc. | 2005 | — |
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 | 2 | 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? (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 |
|---|---|---|---|
| * | K023621 | Bioflex Professional Therapy SystemSummary page 1…te Devices Predicate devices to the CL1000 IR Laser System include, but not limited to, the Meditech International Inc BioFlex Professional Therapy System (K023621), the Dynatronics Solaris D890 Therapy Probe (K040729), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K… | 2003 |
| * | K040729 | Solaris D890 Therapy ProbeSummary page 1…stem include, but not limited to, the Meditech International Inc BioFlex Professional Therapy System (K023621), the Dynatronics Solaris D890 Therapy Probe (K040729), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), Medical Laser Therapeutics, LP MLT-1000 IR La… | 2004 |
| * | K001179 | Super Nova, AcubeamSummary page 1…Flex Professional Therapy System (K023621), the Dynatronics Solaris D890 Therapy Probe (K040729), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), Medical Laser Therapeutics, LP MLT-1000 IR Laser System (K033986) and the Spectrum Laser & Technologies, Inc. Neu… | 2000 |
| * | K033986 | MLT-1000 IR Laser SystemSummary page 1…D890 Therapy Probe (K040729), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), Medical Laser Therapeutics, LP MLT-1000 IR Laser System (K033986) and the Spectrum Laser & Technologies, Inc. Neurolase Series (K032787). These devices were cleared for introduction… | 2004 |
| * | K032787 | Neurolase, Models 150V, 150C, 1064Summary page 1…Acubeam Systems (K001179), Medical Laser Therapeutics, LP MLT-1000 IR Laser System (K033986) and the Spectrum Laser & Technologies, Inc. Neurolase Series (K032787). These devices were cleared for introduction into interstate commerce via the FDA's 510(k) Notification process.… | 2003 |
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 17 years and passes through 6 companies; a new generation was cleared every 8 months on median.
- None of the 21 ancestors has a recall.
- 7 other devices also cite its predicate K023621.
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 CI1000 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/K053201 · printed Nov 4, 2026
Cite this page
510(k) Report. “K053201: Curae'lase CL1000 IR 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/K053201
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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