510(k) · Cleared
ClearedPalomar Luxir Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palomar Medical Technologies, Inc. · ILY Lamp, Infrared, Therapeutic Heating
Cleared on Jun 15, 2005 as substantially equivalent to K033768 (Altus Medical, Inc., 2004) after a 121-day review. Its family tree reaches back 4 generations to 1987. 239 later devices descend from it.
- Decided
- Jun 15, 2005
- Review
- 121 days
- Class
- Class II
- Product code
- ILY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K871179 (1987). 17 ancestors in all. 239 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK871179 Opn Xii ULAragona AB Co. · 1987
- 3 generations backK982636 Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998
- 2 generations backK022609 Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003
- 1 generation backK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
- This deviceK050370 Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005
- Descendant · cites it directly · 184 of its ownK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- Descendant · 2 generations on · 124 of its ownK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
- Descendant · 3 generations on · 118 of its ownK112031 Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for…Alma Lasers, Inc. · 2011
- Descendant · cites it directly · 64 of its ownK070298 Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2007
- Descendant · 2 generations on · 58 of its ownK083595 EzlaseBiolase Technology, Inc. · 2009
Showing 5 of 239 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 239 · See all- K080318Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008 · cites it directly184descendants
- K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010 · 2 generations on124descendants
- K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc. · 2011 · 3 generations on118descendants
- K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2007 · cites it directly64descendants
- K083595EzlaseBiolase Technology, Inc. · 2009 · 2 generations on58descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K871179 | Opn Xii UL | Aragona AB Co. | 1987 | — |
| −3 | K982636 | Patient Warmer- Model PW810 | Fisher & Paykel Healthcare, Ltd. | 1998 | — |
| −2 | K022609 | Surgical Patient Warmer, Model PW820 Jhu | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| −1 | K033768 | Altus Medical Optional Infrared Handpiece | Altus Medical, Inc. | 2004 | — |
| 0 (this device) | K050370 | Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2005 | — |
| +1 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| +2 | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms | Alma Lasers, Inc. | 2010 | — |
| +3 | K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with… | Alma Lasers, Inc. | 2011 | — |
| +1 | K070298 | Modification to Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2007 | — |
| +2 | K083595 | Ezlase | Biolase Technology, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 0 |
| 2014 | 5 | 0 |
| 2015 | 10 | 0 |
| 2016 | 14 | 0 |
| 2017 | 9 | 0 |
| 2018 | 13 | 0 |
| 2019 | 13 | 0 |
| 2020 | 23 | 0 |
| 2021 | 18 | 0 |
| 2022 | 24 | 0 |
| 2023 | 19 | 0 |
| 2024 | 26 | 0 |
| 2025 | 31 | 0 |
| 2026 | 17 | 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? (1)
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 |
|---|---|---|---|
| * | K033768 | Altus Medical Optional Infrared HandpieceSummary page 1…nfrared Handpiece Classification Name: Infrared Heating Lamp (21 CFR 890.5500). Legally-Marketed Predicate Device: K033768 Cutera Optional Infrared Handpiece System Description: T… | 2004 |
What descends from it? (239)
See all 2393 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 18 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 17 ancestors has a recall of any class.
- Of its descendants, K080318 (Alma Lasers, Ltd., 2008) has gone furthest, with 184 descendants of its own.
- 3 other devices also cite its predicate K033768.
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 Palomar LuxlR Handpiece is intended to provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, the Palomar LuxlR Handpiece may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K050370 · printed Nov 6, 2026
Cite this page
510(k) Report. “K050370: Palomar Luxir Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K050370
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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