510(k) · Cleared
ClearedModification to Palomar Luxir 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 Jul 3, 2007 as substantially equivalent to K060069 (Palomar Medical Technologies, Inc., 2006) and 1 other predicate after a 153-day review. Its family tree reaches back 5 generations to 1987. 64 later devices descend from it.
- Decided
- Jul 3, 2007
- Review
- 153 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K871179 (1987). 27 ancestors in all, the oldest K842810 (1984). 64 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK871179 Opn Xii ULAragona AB Co. · 1987
- 4 generations backK982636 Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998
- 3 generations backK022609 Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003
- 2 generations backK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
- 1 generation backK050370 Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005
- This deviceK070298 Modification to Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2007
- Descendant · cites it directly · 57 of its ownK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- Descendant · 2 generations on · 41 of its ownK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- Descendant · 3 generations on · 38 of its ownK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- Descendant · 3 generations on · 24 of its ownK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- Descendant · 2 generations on · 13 of its ownK142376 Palomar Icon Aesthetic SystemCynosure, Inc. · 2014
Showing 5 of 64 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 64 · See all- K110907Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011 · cites it directly57descendants
- K130028Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013 · 2 generations on41descendants
- K142860Lumenis M22 SystemLumenis, Ltd. · 2015 · 3 generations on38descendants
- K170060M22 and ResurFx SystemsLumenis, Ltd. · 2017 · 3 generations on24descendants
- K142376Palomar Icon Aesthetic SystemCynosure, Inc. · 2014 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K871179 | Opn Xii UL | Aragona AB Co. | 1987 | — |
| −4 | K982636 | Patient Warmer- Model PW810 | Fisher & Paykel Healthcare, Ltd. | 1998 | — |
| −3 | K022609 | Surgical Patient Warmer, Model PW820 Jhu | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| −2 | K033768 | Altus Medical Optional Infrared Handpiece | Altus Medical, Inc. | 2004 | — |
| −1 | K050370 | Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2005 | — |
| 0 (this device) | K070298 | Modification to Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2007 | — |
| +1 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| +2 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| +3 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| +3 | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
| +2 | K142376 | Palomar Icon Aesthetic System | Cynosure, Inc. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 1 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1991 | 2 | 0 |
| 1995 | 2 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 1999 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 3 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 4 | 0 |
| 2019 | 1 | 0 |
| 2020 | 7 | 0 |
| 2021 | 5 | 0 |
| 2022 | 5 | 0 |
| 2023 | 4 | 0 |
| 2024 | 9 | 0 |
| 2025 | 10 | 0 |
| 2026 | 4 | 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? (2)
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 |
|---|---|---|---|
| * | K060069 | Palomar Luxir Fractional HandpieceSummary page 1…21 CFR §878.4810 PRODUCT CODE: GEX, ILY 3. PREDICATE DEVICES StarLux LuxiR Handpiece Palomar Medical Technologies, Inc. (K060069 & K050370) 4. INTENDED USE The LuxIR is intended for photocoagulation of soft tissue in dermatologic… | 2006 |
| * | K050370 | Palomar Luxir HandpieceSummary page 1…878.4810 PRODUCT CODE: GEX, ILY 3. PREDICATE DEVICES StarLux LuxiR Handpiece Palomar Medical Technologies, Inc. (K060069 & K050370) 4. INTENDED USE The LuxIR is intended for photocoagulation of soft tissue in dermatologic applicati… | 2005 |
What descends from it? (64)
See all 642 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 20 years and passes through 4 companies; a new generation was cleared every 2.0 years on median.
- 1 of the 27 ancestors has a recall of any class.
- Of its descendants, K110907 (Palomar Medical Technologies, Inc., 2011) has gone furthest, with 57 descendants of its own.
- 1 other device also cites its predicate K060069.
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 LuxIR Handpiece is intended for:
Photocoagulation of soft tissue in dermatologic applications.
Provide topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain and stiffness, the temporary relief of minor joint pain associated with arthritis, the temporary increase in local circulation where applied, and the relaxation of muscles. In addition, it may also help muscle spasms, minor sprains and strains, and minor muscular back pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070298 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070298: Modification to Palomar Luxir Handpiece.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070298
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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