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 Nov 20, 2009 as substantially equivalent to K080244 (Palomar Medical Products, Inc., 2008) and 3 other predicates after a 297-day review. Its family tree reaches back 13 generations to 1992. 158 later devices descend from it.
- Decided
- Nov 20, 2009
- Review
- 297 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 13 generations to K910422 (1992). 135 ancestors in all, the oldest K820106 (1982). 158 later devices descend from it, 4 citing it directly.
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations between
- 3 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 2 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 1 generation backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- This deviceK090195 Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc. · 2009
- Descendant · cites it directly · 157 of its ownK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- Descendant · cites it directly · 156 of its ownK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- Descendant · cites it directly · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- Descendant · 2 generations on · 70 of its ownK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- Descendant · 3 generations on · 62 of its ownK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
Show all 13 generations
- Root · 13 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 12 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 11 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 10 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 9 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 8 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 7 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 6 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 5 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 4 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 3 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 2 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 1 generation backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- This deviceK090195 Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc. · 2009
Showing 5 of 158 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 158 · See all- K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010 · cites it directly157descendants
- K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010 · cites it directly156descendants
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · cites it directly111descendants
- K132806Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014 · 2 generations on70descendants
- K143723SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015 · 3 generations on62descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −12 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −11 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −10 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −9 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −8 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −7 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −6 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −5 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −4 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −3 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −2 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −1 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| 0 (this device) | K090195 | Palomar LUX1540 Handpiece | Palomar Medical Technologies, Inc. | 2009 | — |
| +1 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| +1 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| +1 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| +2 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| +3 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 12 | 0 |
| 1995 | 9 | 0 |
| 1996 | 12 | 0 |
| 1997 | 10 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 11 | 0 |
| 2001 | 9 | 0 |
| 2002 | 11 | 0 |
| 2003 | 9 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 4 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 6 | 0 |
| 2017 | 7 | 0 |
| 2018 | 10 | 0 |
| 2019 | 6 | 0 |
| 2020 | 16 | 0 |
| 2021 | 10 | 0 |
| 2022 | 20 | 0 |
| 2023 | 13 | 0 |
| 2024 | 18 | 0 |
| 2025 | 22 | 0 |
| 2026 | 12 | 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? (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 |
|---|---|---|---|
| * | K080244 | Palomar Lux 1540 HandpieceSummary page 1…PRODUCT CODE: GEX 3. PREDICATE DEVICES Palomar Medical Technologies, Inc. Lux I54OTM Fractional Laser Handpiece K080244 Reliant Technologies, Inc. Fraxel SR1500 Laser System (Fraxel Re:store TM) K070284 Cynosu… | 2008 |
| * | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System)Summary page 1…Lux I54OTM Fractional Laser Handpiece K080244 Reliant Technologies, Inc. Fraxel SR1500 Laser System (Fraxel Re:store TM) K070284 Cynosure, Inc. Affirni Family Laser with XPL I-landpiece K080006 Global USA Distribution,… | 2007 |
| * | K080006 | Affirm with XPL Handpiece and ER:Yag Laser ModuleSummary page 1…, Inc. Fraxel SR1500 Laser System (Fraxel Re:store TM) K070284 Cynosure, Inc. Affirni Family Laser with XPL I-landpiece K080006 Global USA Distribution, LLC. NannoLight IPL System K082033 4. INTENDED USE… | 2008 |
| * | K082033 | Nannolight Intense Pulsed Light SystemSummary page 1…Cynosure, Inc. Affirni Family Laser with XPL I-landpiece K080006 Global USA Distribution, LLC. NannoLight IPL System K082033 4. INTENDED USE The Palomar Lux 1540 Handpiece is intended for use in coagulation of soft tissue, sk… | 2008 |
What descends from it? (158)
See all 1584 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 17 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 5 of the 135 ancestors have a recall of any class.
- Of its descendants, K100270 (Palomar Medical Technologies, Inc., 2010) has gone furthest, with 157 descendants of its own.
- 3 other devices also cite its predicate K080244.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
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 Palomar LuxI54OTM Handpiece is intended for use in:
Coagulation of soft tissue;
Skin resurfacing procedures;
Treatment of melasma and striae;
Treatment of acne scars and surgical scars.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090195 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090195: Palomar LUX1540 Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090195
Report an extraction error
Are you the manufacturer?
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