510(k) · Cleared
ClearedPalomar LUX2940 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 Feb 9, 2007 as substantially equivalent to K000023 (Innotech USA, Inc., 2000) and 4 other predicates after a 72-day review. Its family tree reaches back 9 generations to 1992. 160 later devices descend from it.
- Decided
- Feb 9, 2007
- Review
- 72 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 9 generations to K910422 (1992). 156 ancestors in all, the oldest K820106 (1982). 160 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 2 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 1 generation backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- This deviceK063571 Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc. · 2007
- Descendant · cites it directly · 159 of its ownK071152 Palomar Erbium HandpiecePalomar Medical Products, Inc. · 2007
- 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
- Descendant · 2 generations on · 111 of its ownK101916 Joule Multi-Platform SystemSciton, Inc · 2011
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 4 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 3 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 2 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 1 generation backK042000 Modified MSQ Family of Lovely Light/Laser SystemsMsq (M2), Ltd. · 2004
- This deviceK063571 Palomar LUX2940 HandpiecePalomar Medical Technologies, Inc. · 2007
Showing 5 of 160 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 160 · See all- K071152Palomar Erbium HandpiecePalomar Medical Products, Inc. · 2007 · cites it directly159descendants
- 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
- K101916Joule Multi-Platform SystemSciton, Inc · 2011 · 2 generations on111descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −4 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −3 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −2 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −1 | K042000 | Modified MSQ Family of Lovely Light/Laser Systems | Msq (M2), Ltd. | 2004 | — |
| 0 (this device) | K063571 | Palomar LUX2940 Handpiece | Palomar Medical Technologies, Inc. | 2007 | — |
| +1 | K071152 | Palomar Erbium Handpiece | Palomar Medical Products, Inc. | 2007 | — |
| +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 | — |
| +2 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1991 | 4 | 0 |
| 1993 | 8 | 0 |
| 1994 | 8 | 0 |
| 1995 | 8 | 0 |
| 1996 | 9 | 0 |
| 1997 | 13 | 0 |
| 1998 | 10 | 0 |
| 1999 | 7 | 0 |
| 2000 | 15 | 0 |
| 2001 | 19 | 0 |
| 2002 | 22 | 0 |
| 2003 | 14 | 0 |
| 2004 | 6 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2009 | 1 | 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 |
|---|---|---|---|
| * | K000023 | Friendly Light ER:Yag Pulsed LaserSummary page 1…and in dermatology (21 CFR §878.4810) PRODUCT CODE: GEX 3. PREDICATE DEVICES Friendly Light (K000023) Innotech USA Contour Profile (KO1 0285 & K040005) Sciton, Inc. Harmony Lovely II (K042000)… | 2000 |
| * | K010285 | Contour Profile Laser | 2001 |
| * | K040005 | Profile 2000/3000 Laser SystemSummary page 1…§878.4810) PRODUCT CODE: GEX 3. PREDICATE DEVICES Friendly Light (K000023) Innotech USA Contour Profile (KO1 0285 & K040005) Sciton, Inc. Harmony Lovely II (K042000) Alma Lasers Inc. (formerly MSq (M2) Ltd.) Dermablate (K98… | 2004 |
| * | K042000 | Modified MSQ Family of Lovely Light/Laser SystemsSummary page 1…. PREDICATE DEVICES Friendly Light (K000023) Innotech USA Contour Profile (KO1 0285 & K040005) Sciton, Inc. Harmony Lovely II (K042000) Alma Lasers Inc. (formerly MSq (M2) Ltd.) Dermablate (K980361) Aesculap-Meditec PALOMAR MEDICAL TECHNOLOG… | 2004 |
| * | K980361 | Dermablate ER: Yag Laser SystemSummary page 1…Contour Profile (KO1 0285 & K040005) Sciton, Inc. Harmony Lovely II (K042000) Alma Lasers Inc. (formerly MSq (M2) Ltd.) Dermablate (K980361) Aesculap-Meditec PALOMAR MEDICAL TECHNOLOGIES, INC. CONFIDENTIAL Lux2940 510(K) ==… | 1998 |
What descends from it? (160)
See all 1603 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 15 years and passes through 7 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 156 ancestors have a recall of any class.
- Of its descendants, K071152 (Palomar Medical Products, Inc., 2007) has gone furthest, with 159 descendants of its own.
- 2 other devices also cite its predicate K000023.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Lux2940 handpiece is intended for use in surgical applications requiring the excision, incision, ablation, vaporization, and coagulation of soft tissue. Soft tissue includes skin, cutaneous tissue, subcutaneous tissue, striated and smooth tissue, muscle, cartilage meniscus, calculi or fragments, mucous membrane, lymph vessels and nodes, organs, and glands in the following indications:
• Skin resurfacing
* Treatment of wrinkles
* Epidermal nevi
* Telangiectasia
* Spider veins
* Actinic chelitis
• Keloids
* Verrucae
* Skin tags
* Anal tags
* Keratoses
* Scar revision (including acne scars)
* Debulking benign tumors
* Debulking cysts
* Superficial skin lesions
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063571 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063571: Palomar LUX2940 Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063571
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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