510(k) · Cleared
ClearedAlma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma Lasers, Ltd. · GEX Powered Laser Surgical Instrument
Cleared on Jun 27, 2008 as substantially equivalent to K063001 (Lasering S.R.L., 2007) and 6 other predicates after a 326-day review. Its family tree reaches back 15 generations to 1995. 3 later devices descend from it.
- Decided
- Jun 27, 2008
- Review
- 326 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 15 generations to K943450 (1995). 273 ancestors in all, the oldest K800617 (1980). 3 later devices descend from it, 1 citing it directly.
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 11 generations between
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK072182 Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd. · 2008
- Descendant · cites it directly · 2 of its ownK101321 Ematrix CO2Syneron Medical, Ltd. · 2010
- Descendant · 2 generations on · 1 of its ownK151655 CO2RE SystemSyneron Medical, Ltd. · 2015
- Descendant · 3 generations on · 0 of its ownK181523 Syneron CO2RE SystemSyneron-Candela Corp · 2018
Show all 15 generations
- Root · 15 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 13 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 12 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 11 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 10 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 9 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 8 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 7 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 6 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 5 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 4 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 3 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 2 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 1 generation backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- This deviceK072182 Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060Alma Lasers, Ltd. · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −14 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −13 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −12 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −11 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −10 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −9 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −8 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −7 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −6 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −5 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −4 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −3 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −2 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −1 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| 0 (this device) | K072182 | Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060 | Alma Lasers, Ltd. | 2008 | — |
| +1 | K101321 | Ematrix CO2 | Syneron Medical, Ltd. | 2010 | — |
| +2 | K151655 | CO2RE System | Syneron Medical, Ltd. | 2015 | — |
| +3 | K181523 | Syneron CO2RE System | Syneron-Candela Corp | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 16 | 0 |
| 1995 | 14 | 0 |
| 1996 | 20 | 0 |
| 1997 | 22 | 0 |
| 1998 | 17 | 0 |
| 1999 | 11 | 0 |
| 2000 | 23 | 0 |
| 2001 | 25 | 0 |
| 2002 | 31 | 0 |
| 2003 | 24 | 0 |
| 2004 | 13 | 0 |
| 2005 | 9 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 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? (7)
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 |
|---|---|---|---|
| * | K063001 | Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesSummary page 1…fication Names: Accessory for, Laser Powered Surgical Instruments 1II. Predicate Devices * Lasering SLIM Evolution Family Of CO 2 Lasers and Accessories (K063001) * Lumenis ActiveFx with UltraPulse Encore (K022060) * Lumenis UltraPulse with Scanner (K963339 and K951812)… | 2007 |
| * | K022060 | Lumenis Ultrapulse Encore Carbon Dioxide Surgical Lasers and Delivery Device AccessoriesSummary page 1…nts 1II. Predicate Devices * Lasering SLIM Evolution Family Of CO 2 Lasers and Accessories (K063001) * Lumenis ActiveFx with UltraPulse Encore (K022060) * Lumenis UltraPulse with Scanner (K963339 and K951812) * Reliant Technologies Fraxel SRI1500 Laser Systems… | 2002 |
| * | K963339 | Coherent Ultrapulse CO2 Surgical LasersSummary page 1…SLIM Evolution Family Of CO 2 Lasers and Accessories (K063001) * Lumenis ActiveFx with UltraPulse Encore (K022060) * Lumenis UltraPulse with Scanner (K963339 and K951812) * Reliant Technologies Fraxel SRI1500 Laser Systems and Accessories (K070284) * MSq Family of Lo… | 1997 |
| * | K951812 | Modified Coherent Ultrapulse CO2 Surgical LasersSummary page 1…on Family Of CO 2 Lasers and Accessories (K063001) * Lumenis ActiveFx with UltraPulse Encore (K022060) * Lumenis UltraPulse with Scanner (K963339 and K951812) * Reliant Technologies Fraxel SRI1500 Laser Systems and Accessories (K070284) * MSq Family of Lovely Light/L… | 1995 |
| * | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System)Summary page 1…raPulse Encore (K022060) * Lumenis UltraPulse with Scanner (K963339 and K951812) * Reliant Technologies Fraxel SRI1500 Laser Systems and Accessories (K070284) * MSq Family of Lovely Light/Laser Systems (K042000) * Alma Lasers Harmony XL Multi-Application Platform and… | 2007 |
| * | K042000 | Modified MSQ Family of Lovely Light/Laser SystemsSummary page 1…anner (K963339 and K951812) * Reliant Technologies Fraxel SRI1500 Laser Systems and Accessories (K070284) * MSq Family of Lovely Light/Laser Systems (K042000) * Alma Lasers Harmony XL Multi-Application Platform and Thermoelectric Cooler (K072564) IV. Produc… | 2004 |
| * | K072564 | Alma Lasers Harmony XL Multi-Application Platform Cleared while this submission was under review Summary page 1…284) * MSq Family of Lovely Light/Laser Systems (K042000) * Alma Lasers Harmony XL Multi-Application Platform and Thermoelectric Cooler (K072564) IV. Product Description The Alma Lasers Family of Thermo-XEL Handpieces is comprised of the following main… | 2008 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101321 | Ematrix CO2 | 2010 | 2 |
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 13 years and passes through 6 companies; a new generation was cleared every 9 months on median.
- 10 of the 273 ancestors have a recall of any class.
- Of its descendants, K101321 (Syneron Medical, Ltd., 2010) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K063001.
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 Alma Lasers Family of Thermo-XEL Handpieces is intended for use in surgical applications requiring the ablation, vaporization, and coagulation of soft tissue for compatible CO 2 and 2940 nm Er:YAG laser systems cleared for use in the medical specialty of Dermatology and Plastic Surgery to which they are attached.
The Alma Lasers Family of Thermo-XEL Handpieces is indicated for use in soft tissue for:
DERMATOLOGY AND PLASTIC SURGERY:
· Skin resurfacing
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072182 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072182: Alma Lasers Family of Thermo-Xel Handpieces, Pixel Models: 2940, 1060.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072182
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