510(k) · Cleared
ClearedPalomar LUX1064 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 Jan 13, 2005 after a 185-day review. The FDA summary names its predicate without a number. 416 later devices descend from it.
- Decided
- Jan 13, 2005
- Review
- 185 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
416 later devices descend from it, 5 citing it directly.
- This deviceK041879 Palomar LUX1064 HandpiecePalomar Medical Technologies, Inc. · 2005
- Descendant · cites it directly · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · cites it directly · 221 of its ownK060033 Profile Multi-Platform SystemSciton, Inc · 2006
- Descendant · 2 generations on · 202 of its ownK073063 15W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008
- Descendant · 2 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · 3 generations on · 192 of its ownK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
Showing 5 of 416 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 416 · See all- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · cites it directly266descendants
- K060033Profile Multi-Platform SystemSciton, Inc · 2006 · cites it directly221descendants
- K07306315W Ceralas D 1470NM Diode LaserBiolitec, Inc. · 2008 · 2 generations on202descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 2 generations on198descendants
- K083613Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008 · 3 generations on192descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K041879 | Palomar LUX1064 Handpiece | Palomar Medical Technologies, Inc. | 2005 | — |
| +1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +1 | K060033 | Profile Multi-Platform System | Sciton, Inc | 2006 | — |
| +2 | K073063 | 15W Ceralas D 1470NM Diode Laser | Biolitec, Inc. | 2008 | — |
| +2 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +3 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 13 | 0 |
| 2009 | 5 | 0 |
| 2010 | 11 | 0 |
| 2011 | 11 | 0 |
| 2012 | 8 | 0 |
| 2013 | 12 | 0 |
| 2014 | 19 | 0 |
| 2015 | 20 | 0 |
| 2016 | 28 | 0 |
| 2017 | 21 | 0 |
| 2018 | 21 | 0 |
| 2019 | 12 | 0 |
| 2020 | 27 | 0 |
| 2021 | 21 | 0 |
| 2022 | 33 | 0 |
| 2023 | 26 | 0 |
| 2024 | 45 | 0 |
| 2025 | 51 | 0 |
| 2026 | 28 | 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 |
|---|---|---|---|
| * | — | StarLux™ Pulsed Light System (handpieces) Named without a submission number | |
| * | — | Lumenis Family of IPL & IPL/NdYAG Named without a submission number | |
| * | — | Candela GentleYAG Named without a submission number | |
| * | — | Laserscope LLRA Named without a submission number | |
| * | — | Laserscope Lyra series Named without a submission number |
What descends from it? (416)
See all 4165 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?
- Of its descendants, K072564 (Alma Lasers, Ltd., 2008) has gone furthest, with 266 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 Lux 064TM handpiece is indicated for: • The removal of unwanted hair for skin types J-VI, and to effect stable long-term permanent hair reduction. • The treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, ehloasma, caf&-au-Iait macules, and plaques. • Verrucae, skin tags, seborrheic keratosis. • Tattoos (significant reduction in the…
Read the full statement (174 words)
The Lux 064TM handpiece is indicated for:
• The removal of unwanted hair for skin types J-VI, and to effect stable long-term permanent hair reduction.
• The treatment of benign pigmented lesions such as, but not limited to, senile lentigines (age spots), solar lentigos (sun spots), pigmented seborrheic keratoses, nevi, ehloasma, caf&-au-Iait macules, and plaques.
• Verrucae, skin tags, seborrheic keratosis.
• Tattoos (significant reduction in the intensity of black and/or blue-black tattoos).
• The Lux1064T M is indicated for pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from'aggressive treatment, and for patients with lesions that have not responded to other laser/light treatments. The treatment of vascular lesions such as but not limited to, port wine stains, hemangiomas, telangiectasias, rosacea, Venus lake, facial and leg veins.
• The LuxL064 TM is also indicated for the reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar.
• Coagulation and hemostasis of soft tissue.
• Treatment of wrinkles.
• Pseudofolliculitis barbae (PFB)
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041879 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041879: Palomar LUX1064 Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041879
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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