510(k) · Cleared
ClearedPalomar Luxir Fractional Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palomar Medical Technologies, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Mar 2, 2006 as substantially equivalent to K990850 (CooperSurgical, Inc., 1999) and 2 other predicates after a 52-day review. Its family tree reaches back 2 generations to 1984. 107 later devices descend from it.
- Decided
- Mar 2, 2006
- Review
- 52 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K842810 (1984). 8 ancestors in all. 107 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK842810 Infrared CoagulatorEndo Lase, Inc. · 1984
- 1 generation backK974168 Coopersurgical Infrared CoagulatorHogan & Hartson · 1998
- This deviceK060069 Palomar Luxir Fractional HandpiecePalomar Medical Technologies, Inc. · 2006
- Descendant · cites it directly · 64 of its ownK070298 Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2007
- Descendant · 2 generations on · 57 of its ownK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- Descendant · cites it directly · 56 of its ownK111303 Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011
- Descendant · 3 generations on · 41 of its ownK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- Descendant · 4 generations on · 38 of its ownK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
Showing 5 of 107 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 107 · See all- K070298Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2007 · cites it directly64descendants
- K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011 · 2 generations on57descendants
- K111303Dermatological Treatment Device FamilySharplight Technologies, Ltd. · 2011 · cites it directly56descendants
- K130028Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013 · 3 generations on41descendants
- K142860Lumenis M22 SystemLumenis, Ltd. · 2015 · 4 generations on38descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842810 | Infrared Coagulator | Endo Lase, Inc. | 1984 | — |
| −1 | K974168 | Coopersurgical Infrared Coagulator | Hogan & Hartson | 1998 | — |
| 0 (this device) | K060069 | Palomar Luxir Fractional Handpiece | Palomar Medical Technologies, Inc. | 2006 | — |
| +1 | K070298 | Modification to Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2007 | — |
| +2 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| +1 | K111303 | Dermatological Treatment Device Family | Sharplight Technologies, Ltd. | 2011 | — |
| +3 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| +4 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1991 | 2 | 0 |
| 1995 | 2 | 0 |
| 1999 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 3 | 0 |
| 2016 | 10 | 0 |
| 2017 | 7 | 0 |
| 2018 | 5 | 0 |
| 2019 | 4 | 0 |
| 2020 | 11 | 0 |
| 2021 | 8 | 0 |
| 2022 | 7 | 0 |
| 2023 | 7 | 0 |
| 2024 | 12 | 0 |
| 2025 | 16 | 0 |
| 2026 | 7 | 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 GEX? 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 GEX device
- #1 K222064 The Alma Soprano Titaniumscore 38.1 · 24 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K990850 | Coopersurgical Coagulator for Tattoo RemovalSummary page 1…Common Name: LuxIR Photocoagulator Classification Panel: General and Plastic Surgery (878.4810) Legally-Marketed Predicate Device: K990850; K974168; K911648 Coopersurgical/Redfield Infrared Coagulator System Description:… | 1999 |
| * | K974168 | Coopersurgical Infrared CoagulatorSummary page 1…Name: LuxIR Photocoagulator Classification Panel: General and Plastic Surgery (878.4810) Legally-Marketed Predicate Device: K990850; K974168; K911648 Coopersurgical/Redfield Infrared Coagulator System Description:… | 1998 |
| * | K911648 | Redfield Infrared CoagulatorSummary page 1…LuxIR Photocoagulator Classification Panel: General and Plastic Surgery (878.4810) Legally-Marketed Predicate Device: K990850; K974168; K911648 Coopersurgical/Redfield Infrared Coagulator System Description:… | 1991 |
What descends from it? (107)
See all 1072 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 22 years and passes through 3 companies; a new generation was cleared every 13.3 years on median.
- None of the 8 ancestors has a recall.
- Of its descendants, K070298 (Palomar Medical Technologies, Inc., 2007) has gone furthest, with 64 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · GEX
83in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · GEX
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · GEX
3in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · GEX
2,720in 2025
MAUDE reports naming product code GEX, 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 | 73 | 79 | 9 | 342 |
| 2008 | 107 | 86 | 2 | 232 |
| 2009 | 69 | 100 | 0 | 209 |
| 2010 | 50 | 96 | 4 | 1,711 |
| 2011 | 41 | 83 | 18 | 3,024 |
| 2012 | 45 | 118 | 5 | 2,000 |
| 2013 | 46 | 144 | 3 | 2,236 |
| 2014 | 61 | 147 | 6 | 2,036 |
| 2015 | 47 | 112 | 0 | 2,099 |
| 2016 | 51 | 114 | 1 | 2,585 |
| 2017 | 67 | 90 | 5 (1) | 2,977 |
| 2018 | 51 | 78 | 5 | 3,525 |
| 2019 | 41 | 88 | 6 | 2,709 |
| 2020 | 52 | 90 | 1 | 2,183 |
| 2021 | 53 | 123 | 0 | 3,465 |
| 2022 | 60 | 152 | 0 | 2,288 |
| 2023 | 52 | 87 | 6 | 2,337 |
| 2024 | 82 | 90 | 3 | 2,187 |
| 2025 | 83 | 90 | 0 | 2,720 |
| 2026 | 57 | 90 | 2 | — |
What is it indicated for?
The LuxIR is intended for the photocoagulation of soft tissue in dermatologic applications including but not limited to the treatment of warts and tattoos.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060069 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060069: Palomar Luxir Fractional Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060069
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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