510(k) · Cleared
ClearedPalomar LUX1540 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 23, 2006 as substantially equivalent to K031795 (Reliant Technologies, Inc., 2003) after a 45-day review. Its family tree reaches back 6 generations to 1994. 260 later devices descend from it.
- Decided
- Mar 23, 2006
- Review
- 45 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K936109 (1994). 26 ancestors in all, the oldest K822136 (1982). 260 later devices descend from it, 3 citing it directly.
- Root · 6 generations backK936109 Sharplan Model 1120 CO2 Surgical LaserSharplan Lasers, Inc. · 1994
- 5 generations backK960521 Sharplan Lasers, Inc. Silktouch Flash ScannerSharplan Lasers, Inc. · 1996
- 4 generations backK963339 Coherent Ultrapulse CO2 Surgical LasersCoherent Medical Group · 1997
- 3 generations backK974789 Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and LLumenis, Inc. · 1998
- 2 generations backK022060 Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and…Lumenis, Inc. · 2002
- 1 generation backK031795 Reliant Laser SystemReliant Technologies, Inc. · 2003
- This deviceK060301 Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc. · 2006
- Descendant · cites it directly · 259 of its ownK061652 Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2007
- Descendant · cites it directly · 161 of its ownK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- Descendant · 2 generations on · 159 of its ownK073583 Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2008
- Descendant · 2 generations on · 158 of its ownK090195 Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc. · 2009
- Descendant · 2 generations on · 158 of its ownK091446 Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc. · 2009
Showing 5 of 260 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 260 · See all- K061652Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2007 · cites it directly259descendants
- K080244Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008 · cites it directly161descendants
- K073583Modification to Palomar LUX1540 HandpiecePalomar Medical Products, Inc. · 2008 · 2 generations on159descendants
- K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc. · 2009 · 2 generations on158descendants
- K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc. · 2009 · 2 generations on158descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K936109 | Sharplan Model 1120 CO2 Surgical Laser | Sharplan Lasers, Inc. | 1994 | — |
| −5 | K960521 | Sharplan Lasers, Inc. Silktouch Flash Scanner | Sharplan Lasers, Inc. | 1996 | — |
| −4 | K963339 | Coherent Ultrapulse CO2 Surgical Lasers | Coherent Medical Group | 1997 | — |
| −3 | K974789 | Coherent Ultrapulse S Series CO2 Surgical Lasers Model C and L | Lumenis, Inc. | 1998 | — |
| −2 | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device… | Lumenis, Inc. | 2002 | — |
| −1 | K031795 | Reliant Laser System | Reliant Technologies, Inc. | 2003 | — |
| 0 (this device) | K060301 | Palomar LUX1540 Handpiece | Palomar Medical Technologies, Inc. | 2006 | — |
| +1 | K061652 | Palomar LUX1540 Handpiece | Palomar Medical Products, Inc. | 2007 | — |
| +1 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| +2 | K073583 | Modification to Palomar LUX1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| +2 | K090195 | Palomar LUX1540 Handpiece | Palomar Medical Technologies, Inc. | 2009 | — |
| +2 | K091446 | Modification to LUX1540 Handpiece and Lux 1440 Handpiece | Palomar Medical Products, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1994 | 4 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 3 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2012 | 4 | 0 |
| 2013 | 3 | 0 |
| 2014 | 6 | 0 |
| 2015 | 7 | 0 |
| 2016 | 10 | 0 |
| 2017 | 10 | 0 |
| 2018 | 14 | 0 |
| 2019 | 8 | 0 |
| 2020 | 23 | 0 |
| 2021 | 16 | 0 |
| 2022 | 29 | 0 |
| 2023 | 19 | 0 |
| 2024 | 37 | 0 |
| 2025 | 34 | 0 |
| 2026 | 23 | 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? (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 |
|---|---|---|---|
| * | K031795 | Reliant Laser SystemSummary page 1…878.4810) Product Code: GEX Legally-Marketed Predicate Device: Reliant Fraxel K031795 System Description: The Palomar Luxl540 Handpiece delivers light… | 2003 |
What descends from it? (260)
See all 2603 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 12 years and passes through 5 companies; a new generation was cleared every 1.9 years on median.
- None of the 26 ancestors has a recall.
- Of its descendants, K061652 (Palomar Medical Products, Inc., 2007) has gone furthest, with 259 descendants of its own.
- 5 other devices also cite its predicate K031795.
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?
Dermatological procedures requiring the coagulation of soft tissue.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K060301 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060301: Palomar LUX1540 Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060301
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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