510(k) · Cleared
ClearedPhoenix Thera-Lase System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Phoenix Thera-Lase Systems, LLC · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Sep 4, 2015 as substantially equivalent to K120604 (Eltech S.R.L, 2012) and 3 other predicates after a 91-day review. Its family tree reaches back 8 generations to 1988.
- Decided
- Sep 4, 2015
- Review
- 91 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K875052 (1988). 37 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backK875052 TDP, Lark Brand and Mit LampI.E.C. Co. · 1988
- 7 generations backK020851 TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B…C&H International · 2002
- 6 generations backK024179 Palomar LightcubePalomar Medical Products, Inc. · 2003
- 5 generations backK032787 Neurolase, Models 150V, 150C, 1064Spectrum Laser & Technologies · 2003
- 4 generations backK033986 MLT-1000 IR Laser SystemMedical Laser Therapeutics LP · 2004
- 3 generations backK053473 Maestro MDTL Laser SystemAdvanced Medical Technologies, Inc. · 2006
- 2 generations backK061656 Laser-D68Laser Pain Clinics LP · 2006
- 1 generation backK120604 K-LaserEltech S.R.L · 2012
- This deviceK151521 Phoenix Thera-Lase SystemPhoenix Thera-Lase Systems, LLC · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K875052 | TDP, Lark Brand and Mit Lamp | I.E.C. Co. | 1988 | — |
| −7 | K020851 | TDP Heat Lamp or Infrared Heating Lamp, Models CQG-S1, CQG-111A/B, CQG-222A/B… | C&H International | 2002 | — |
| −6 | K024179 | Palomar Lightcube | Palomar Medical Products, Inc. | 2003 | — |
| −5 | K032787 | Neurolase, Models 150V, 150C, 1064 | Spectrum Laser & Technologies | 2003 | — |
| −4 | K033986 | MLT-1000 IR Laser System | Medical Laser Therapeutics LP | 2004 | — |
| −3 | K053473 | Maestro MDTL Laser System | Advanced Medical Technologies, Inc. | 2006 | — |
| −2 | K061656 | Laser-D68 | Laser Pain Clinics LP | 2006 | — |
| −1 | K120604 | K-Laser | Eltech S.R.L | 2012 | — |
| 0 (this device) | K151521 | Phoenix Thera-Lase System | Phoenix Thera-Lase Systems, LLC | 2015 | — |
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 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 4 | 0 |
| 2005 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K120604 | K-LaserSummary page 4…a-Lase System Common Name: Infrared heat lamp Classification: ILY 890.5500 Class 2 Lamp, Infrared, Therapeutic Heating Predicate Device: K120604 K-Laser ELTECH s.r.l. K101893 Nexus Laser USA Laser Biotech Inc… | 2012 |
| * | K101893 | Nexus Biowave 7W Lite IR Lamp System, Nexus Biowave 10W Lite IR Lamp System, Nexus…Summary page 4…ation: ILY 890.5500 Class 2 Lamp, Infrared, Therapeutic Heating Predicate Device: K120604 K-Laser ELTECH s.r.l. K101893 Nexus Laser USA Laser Biotech Inc K122125 ASA Laser El.En. S.p.A… | 2011 |
| * | K122125 | Asa Laser SH1Summary page 4…ing Predicate Device: K120604 K-Laser ELTECH s.r.l. K101893 Nexus Laser USA Laser Biotech Inc K122125 ASA Laser El.En. S.p.A K121363 Diowave Laser Technological Medical Advancements, Inc… | 2013 |
| * | K121363 | Diowave Low Level Cold Laser SystemSummary page 4….r.l. K101893 Nexus Laser USA Laser Biotech Inc K122125 ASA Laser El.En. S.p.A K121363 Diowave Laser Technological Medical Advancements, Inc Device Description: The Phoenix Thera-Lase System is a stand-al… | 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 27 years and passes through 9 companies; a new generation was cleared every 1.9 years on median.
- 1 of the 37 ancestors has a recall of any class.
- 3 other devices also cite its predicate K120604.
How does its category compare?
All ILY devicesILY Lamp, Infrared, Therapeutic Heating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Phoenix Thera-Lase System is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating tissue temperature for temporary relief of minor muscle and joint pain, muscle spasm, pain and stiffness associated with minor arthritis, promoting relaxation of muscle tissue, and to temporarily increase local blood circulation.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K151521 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151521: Phoenix Thera-Lase System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151521
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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