510(k) · Cleared
ClearedSoprano Ice Multi-Application & Multi-Technology Platform
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 Aug 29, 2014 as substantially equivalent to K112031 (Alma Lasers, Inc., 2011) and 6 other predicates after a 239-day review. Its family tree reaches back 19 generations to 1995. 57 later devices descend from it.
- Decided
- Aug 29, 2014
- Review
- 239 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 7
Its longest line of descent runs back 19 generations to K943450 (1995). 514 ancestors in all, the oldest K771218 (1978). 57 later devices descend from it, 7 citing it directly.
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 15 generations between
- 3 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 2 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 1 generation backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- This deviceK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- Descendant · cites it directly · 32 of its ownK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
- Descendant · cites it directly · 22 of its ownK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- Descendant · 2 generations on · 14 of its ownK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022
- Descendant · 2 generations on · 13 of its ownK180719 InMode Diolaze SystemInmode MD, Ltd. · 2018
- Descendant · 2 generations on · 13 of its ownK152714 Quanta ForteQuanta System Spa · 2015
Show all 19 generations
- Root · 19 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 17 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 15 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 14 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 13 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 12 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 11 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 10 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 8 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 7 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 6 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 5 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 4 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 2 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 1 generation backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- This deviceK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
Showing 5 of 57 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 57 · See all- K143519The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015 · cites it directly32descendants
- K172193Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Alma Lasers, Inc. · 2018 · cites it directly22descendants
- K222064The Alma Soprano TitaniumAlma Lasers, Inc. · 2022 · 2 generations on14descendants
- K180719InMode Diolaze SystemInmode MD, Ltd. · 2018 · 2 generations on13descendants
- K152714Quanta ForteQuanta System Spa · 2015 · 2 generations on13descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −19 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −18 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −17 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −15 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −14 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −13 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −12 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −11 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −10 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −8 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −7 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −6 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −5 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −4 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −3 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −2 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −1 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| 0 (this device) | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| +1 | K143519 | The MeDioStar NeXT Family | Asclepion Laser Technologies GmbH | 2015 | — |
| +1 | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology… | Alma Lasers, Inc. | 2018 | — |
| +2 | K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022 | — |
| +2 | K180719 | InMode Diolaze System | Inmode MD, Ltd. | 2018 | — |
| +2 | K152714 | Quanta Forte | Quanta System Spa | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 4 | 0 |
| 1990 | 7 | 0 |
| 1991 | 8 | 0 |
| 1992 | 5 | 0 |
| 1993 | 12 | 0 |
| 1994 | 25 | 0 |
| 1995 | 25 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 30 | 0 |
| 1999 | 26 | 0 |
| 2000 | 34 | 0 |
| 2001 | 34 | 0 |
| 2002 | 42 | 0 |
| 2003 | 47 | 0 |
| 2004 | 34 | 0 |
| 2005 | 28 | 0 |
| 2006 | 15 | 0 |
| 2007 | 16 | 0 |
| 2008 | 18 | 0 |
| 2009 | 7 | 0 |
| 2010 | 3 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 4 | 0 |
| 2020 | 8 | 0 |
| 2021 | 3 | 0 |
| 2022 | 10 | 0 |
| 2023 | 6 | 0 |
| 2024 | 8 | 0 |
| 2025 | 5 | 0 |
| 2026 | 5 | 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 |
|---|---|---|---|
| * | K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Summary page 5…Lamp, Infrared, Therapeutic Heating III. Predicate Devices K # Predicate Device K112031 Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for use with the fa… | 2011 |
| * | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsSummary page 5…e with SHR Treatment Mode for use with the family of Soprano XL Multi-Application Platforms K102716 Modified Alma Lasers Family of Soprano Family XL TM Multi Application Platform (Sop… | 2010 |
| * | K083848 | Alma Lasers Soprano XL Multi-Application PlatformSummary page 5…02716 Modified Alma Lasers Family of Soprano Family XL TM Multi Application Platform (Soprano XL, Soprano XLi). K083848 Alma Lasers Soprano XL Multi-Application Platform K080318 Alma Lasers NIR Module… | 2009 |
| * | K080318 | Alma Laser Nir ModuleSummary page 5…Application Platform (Soprano XL, Soprano XLi). K083848 Alma Lasers Soprano XL Multi-Application Platform K080318 Alma Lasers NIR Module K090571 Alma Lasers Alex755 Module K101916… | 2008 |
| * | K090571 | Alma Lasers ALEX755 ModuleSummary page 5…XL, Soprano XLi). K083848 Alma Lasers Soprano XL Multi-Application Platform K080318 Alma Lasers NIR Module K090571 Alma Lasers Alex755 Module K101916 Sciton Clear Scan K083207 Quant… | 2009 |
| * | K101916 | Joule Multi-Platform SystemSummary page 5…ers Soprano XL Multi-Application Platform K080318 Alma Lasers NIR Module K090571 Alma Lasers Alex755 Module K101916 Sciton Clear Scan K083207 Quanta System Ultrawave III EX 1320 IV. Product Descriptio… | 2011 |
| * | K083207 | Ultrawave Iii EX 1320Summary page 5…K080318 Alma Lasers NIR Module K090571 Alma Lasers Alex755 Module K101916 Sciton Clear Scan K083207 Quanta System Ultrawave III EX 1320 IV. Product Description The Modified Alma Lasers Soprano XL™ Family of M… | 2008 |
| † | K050370 | Palomar Luxir Handpiece | 2005 |
| † | K042165 | Cutera Tabletop Aesthetic Product | 2004 |
What descends from it? (57)
See all 577 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K143519 | The MeDioStar NeXT Family | 2015 | 32 |
| K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms… | 2018 | 22 |
| K191321 | Primelase Excellence | 2019 | 8 |
| K141237 | Harmony Lite | 2015 | 4 |
| K193367 | elysion-pro | 2020 | 3 |
| K193446 | Bare: 808 | 2020 | 2 |
| K222800 | Diode Laser Hair Removal Systems for Medical Use (Models: Milestone Smart-M, Milestone… | 2022 | 0 |
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 19 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 26 of the 514 ancestors have a recall of any class.
- Of its descendants, K143519 (Asclepion Laser Technologies GmbH, 2015) has gone furthest, with 32 descendants of its own.
- 6 other devices also cite its predicate K112031.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano XLi and Soprano ICE] includes Diode Laser and NIR Modules Diode Laser Modules: The indications for use for the 810nm Modified Diode Laser Module 1.2 cm² include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode is intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs…
Read the full statement (353 words)
The Modified Alma Lasers Soprano XL™ Family of Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano XLi and Soprano ICE] includes Diode Laser and NIR Modules
Diode Laser Modules:
The indications for use for the 810nm Modified Diode Laser Module 1.2 cm² include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode is intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
The treatment of benign vascular and pigmented lesions. (The Laser Blanch (LB) Mode)
Use on all skin types (Fitzpatrick I-VI), including tanned skin. (HR, SHR and LB Modes)
Optional Tapered Light Guide: It is intended for the same use as the device.
The indications for use for the 810nm Modified Diode Laser Module 2 cm² include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode is intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
Use on all skin types (Fitzpatrick I-VI), including tanned skin. (HR and SHR Modes)
The indications for use for the 755nm Diode Laser Module include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode is intended for permanent reduction in hair regrowth, defined as a long term, stable reduction in the number of hairs re-growing when measured at 6, 9 and 12 months after the completion of a treatment regimen.
The treatment of benign vascular and pigmented lesions. (The Laser Blanch Mode)
Use on all skin types (Fitzpatrick I-VI), including tanned skin. (HR, SHR and Laser Blanch Modes)
NIR Modules
The indications for use for NIR Modules are:
Elevating the tissue temperature for the temporary relief of minor muscle pain 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; 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/K140009 · printed Nov 6, 2026
Cite this page
510(k) Report. “K140009: Soprano Ice Multi-Application & Multi-Technology Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K140009
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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