510(k) · Cleared
Recalled · Class II · 2014Apollo IR Heat Lamp System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Apollo Physical Therapy Products International · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Mar 21, 2006 as substantially equivalent to K023621 (Meditech International, Inc., 2003) and 5 other predicates after a 62-day review. Its family tree reaches back 6 generations to 2000. 1 later device descends from it. It has been recalled once.
- Decided
- Mar 21, 2006
- Review
- 62 days
- Class
- Class II
- Product code
- ILY
- Recalls
- 1
- Predicates
- 6
Its longest line of descent runs back 6 generations to K001179 (2000). 33 ancestors in all, the oldest K871179 (1987). 1 later device descends from it, 1 citing it directly.
- Root · 6 generations backK001179 Super Nova, AcubeamLight Force Therapy, Inc. · 2000
- 5 generations backK020017 Medx 1000 SeriesMedx Electronics, Inc. · 2002
- 4 generations backK031329 Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared…Dynatronics Corp. · 2003
- 3 generations backK040729 Solaris D890 Therapy ProbeDynatronics Corp. · 2004
- 2 generations backK043586 Laser Sys*Stim 540, Model ME 540Mettler Electronics Corp. · 2005
- 1 generation backK052647 Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300…American Spine Center, Ltd. · 2005
- This deviceK060134 Apollo IR Heat Lamp SystemApollo Physical Therapy Products International · 2006
- Descendant · cites it directly · 0 of its ownK150466 ZX2 Laser SystemLzr7, Inc. · 2015
Most influential descendants
Showing 1 of 1 · See all- K150466ZX2 Laser SystemLzr7, Inc. · 2015 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K001179 | Super Nova, Acubeam | Light Force Therapy, Inc. | 2000 | — |
| −5 | K020017 | Medx 1000 Series | Medx Electronics, Inc. | 2002 | — |
| −4 | K031329 | Dynatron Solaris Series, Models 705, 706, 708, 709 D880 Infrared Probe… | Dynatronics Corp. | 2003 | — |
| −3 | K040729 | Solaris D890 Therapy Probe | Dynatronics Corp. | 2004 | — |
| −2 | K043586 | Laser Sys*Stim 540, Model ME 540 | Mettler Electronics Corp. | 2005 | — |
| −1 | K052647 | Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275… | American Spine Center, Ltd. | 2005 | — |
| 0 (this device) | K060134 | Apollo IR Heat Lamp System | Apollo Physical Therapy Products International | 2006 | — |
| +1 | K150466 | ZX2 Laser System | Lzr7, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1995 | 4 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 3 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 5 | 0 |
| 2004 | 3 | 0 |
| 2005 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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? (6)
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…Predicate devices to the APOLLO IR Heat Lamp System include, but not limited to, the Meditech International Inc BioFlex Professional Therapy System (K023621), Thor International, Ltd. DDII Laser System (K033923), the Dynatronics Solaris D890 Therapy Probe (K040729), Light Force… | 2003 |
| * | K033923 | TH0R Ddii IR Lamp SystemSummary page 1…stem include, but not limited to, the Meditech International Inc BioFlex Professional Therapy System (K023621), Thor International, Ltd. DDII Laser System (K033923), the Dynatronics Solaris D890 Therapy Probe (K040729), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K… | 2004 |
| * | K040729 | Solaris D890 Therapy ProbeSummary page 1…tional Inc BioFlex Professional Therapy System (K023621), Thor International, Ltd. DDII Laser System (K033923), the Dynatronics Solaris D890 Therapy Probe (K040729), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), American Spine Center, LTD. Clini-Lase System… | 2004 |
| * | K001179 | Super Nova, AcubeamSummary page 1…national, Ltd. DDII Laser System (K033923), the Dynatronics Solaris D890 Therapy Probe (K040729), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), American Spine Center, LTD. Clini-Lase Systems (K052647) and the Spectrum Laser & Technologies, Inc. Neurolase Se… | 2000 |
| * | K052647 | Clini-Lase System, Models CL-Base, CL-2000, CL-1200, CL-500, CL-300, CL-275, CL-155…Summary page 1…s Solaris D890 Therapy Probe (K040729), Light Force Therapy, Inc. Super Nova and Acubeam Systems (K001179), American Spine Center, LTD. Clini-Lase Systems (K052647) and the Spectrum Laser & Technologies, Inc. Neurolase Series (K032787). These devices were cleared for introduction into… | 2005 |
| * | K032787 | Neurolase, Models 150V, 150C, 1064Summary page 1…Nova and Acubeam Systems (K001179), American Spine Center, LTD. Clini-Lase Systems (K052647) 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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K150466 | ZX2 Laser System | 2015 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 17, 2014 | Class II | Z-1250-2015 | Device Design | Control units were equipped with an internal mounting kit that does not meet medical safety standards, and are conductive, increasing the risk of electric shock to the user and patient. These units were manufactured prior to Pivotal… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 6 companies; a new generation was cleared every 11 months on median.
- 1 of the 33 ancestors has a recall of any class.
- Of its descendants, K150466 (Lzr7, Inc., 2015) has gone furthest, with 0 descendants of its own.
- 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 APOLLO IR Heat Lamp 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/K060134 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060134: Apollo IR Heat Lamp System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060134
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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