510(k) · Cleared
ClearedPalomar Lux 1540 Handpiece
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Palomar Medical Products, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jun 20, 2008 as substantially equivalent to K060301 (Palomar Medical Technologies, Inc., 2006) and 4 other predicates after a 141-day review. Its family tree reaches back 12 generations to 1992. 161 later devices descend from it.
- Decided
- Jun 20, 2008
- Review
- 141 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 12 generations to K910422 (1992). 132 ancestors in all, the oldest K820106 (1982). 161 later devices descend from it, 4 citing it directly.
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations between
- 3 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 2 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 1 generation backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- This deviceK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- Descendant · cites it directly · 158 of its ownK090195 Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc. · 2009
- Descendant · cites it directly · 158 of its ownK091446 Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc. · 2009
- Descendant · cites it directly · 158 of its ownK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- Descendant · 2 generations on · 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
Show all 12 generations
- Root · 12 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 10 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 9 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 8 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 7 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 6 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 5 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 4 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 3 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 2 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 1 generation backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- This deviceK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
Showing 5 of 161 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 161 · See all- K090195Palomar LUX1540 HandpiecePalomar Medical Technologies, Inc. · 2009 · cites it directly158descendants
- K091446Modification to LUX1540 Handpiece and Lux 1440 HandpiecePalomar Medical Products, Inc. · 2009 · cites it directly158descendants
- K083900Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009 · cites it directly158descendants
- K100270Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010 · 2 generations on157descendants
- K101506LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010 · cites it directly156descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −11 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −10 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −9 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −8 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −7 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −6 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −5 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −4 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −3 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −2 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −1 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| 0 (this device) | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| +1 | K090195 | Palomar LUX1540 Handpiece | Palomar Medical Technologies, Inc. | 2009 | — |
| +1 | K091446 | Modification to LUX1540 Handpiece and Lux 1440 Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| +1 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| +2 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| +1 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 3 | 0 |
| 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? (5)
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 |
|---|---|---|---|
| * | K060301 | Palomar LUX1540 HandpieceSummary page 1…R § 878.4810) PRODUCT CODE: GEX 3. PREDICATE DEVICES Palomar Medical Technologies, Inc. Lux1540 Handpiece K060301 & K061652 Reliant Technologies, Inc. Fraxel SR1500 Laser System (Fraxel Re:store TM) K070284, K… | 2006 |
| * | K061652 | Palomar LUX1540 HandpieceSummary page 1…10) PRODUCT CODE: GEX 3. PREDICATE DEVICES Palomar Medical Technologies, Inc. Lux1540 Handpiece K060301 & K061652 Reliant Technologies, Inc. Fraxel SR1500 Laser System (Fraxel Re:store TM) K070284, K062303, K0… | 2007 |
| * | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System)Summary page 1…c. Lux1540 Handpiece K060301 & K061652 Reliant Technologies, Inc. Fraxel SR1500 Laser System (Fraxel Re:store TM) K070284, K062303, K042319 4. INTENDED USE The Palomar Lux 1540 handpiece is intended for use in dermatological pr… | 2007 |
| * | K062303 | Fraxel II SR Laser SystemSummary page 1…Lux1540 Handpiece K060301 & K061652 Reliant Technologies, Inc. Fraxel SR1500 Laser System (Fraxel Re:store TM) K070284, K062303, K042319 4. INTENDED USE The Palomar Lux 1540 handpiece is intended for use in dermatological procedures… | 2007 |
| * | K042319 | Reliant Laser II System and AccessoriesSummary page 1…540 Handpiece K060301 & K061652 Reliant Technologies, Inc. Fraxel SR1500 Laser System (Fraxel Re:store TM) K070284, K062303, K042319 4. INTENDED USE The Palomar Lux 1540 handpiece is intended for use in dermatological procedures requ… | 2005 |
What descends from it? (161)
See all 1614 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 16 years and passes through 7 companies; a new generation was cleared every 1.1 years on median.
- 4 of the 132 ancestors have a recall of any class.
- Of its descendants, K090195 (Palomar Medical Technologies, Inc., 2009) has gone furthest, with 158 descendants of its own.
- 2 other devices also cite its predicate K060301.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 LuxI540 handpiece is intended for use in dermatological procedures requiring:
Coagulation of soft tissue, skin resurfacing procedures, melasma, acne scars, and surgical scars.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K080244: Palomar Lux 1540 Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K080244
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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