510(k) · Cleared
ClearedModified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alma Lasers, Inc. · GEX Powered Laser Surgical Instrument
Cleared on Jan 9, 2018 as substantially equivalent to K140009 (Alma Lasers, Ltd., 2014) and 1 other predicate after a 172-day review. Its family tree reaches back 23 generations to 1995. 22 later devices descend from it.
- Decided
- Jan 9, 2018
- Review
- 172 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 23 generations to K943450 (1995). 564 ancestors in all, the oldest K771218 (1978). 22 later devices descend from it, 7 citing it directly.
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 19 generations between
- 3 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 2 generations backK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- 1 generation backK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- This deviceK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- Descendant · cites it directly · 14 of its ownK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022
- Descendant · 2 generations on · 2 of its ownK251329 Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd. · 2025
- Descendant · 2 generations on · 2 of its ownK230308 Alma HarmonyAlma Lasers, Inc. · 2023
- Descendant · 2 generations on · 2 of its ownK230371 The Alma Soprano TitaniumAlma Lasers, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK201594 Primelase ExcellenceHigh Technology Products S.L.U · 2020
Show all 23 generations
- Root · 23 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 22 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 19 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 18 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 17 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 16 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 15 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 12 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 11 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 10 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 9 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 8 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 7 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 6 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 5 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 4 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 3 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 2 generations backK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- 1 generation backK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- This deviceK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K222064The Alma Soprano TitaniumAlma Lasers, Inc. · 2022 · cites it directly14descendants
- K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd. · 2025 · 2 generations on2descendants
- K230308Alma HarmonyAlma Lasers, Inc. · 2023 · 2 generations on2descendants
- K230371The Alma Soprano TitaniumAlma Lasers, Inc. · 2023 · 2 generations on2descendants
- K201594Primelase ExcellenceHigh Technology Products S.L.U · 2020 · cites it directly2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −23 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −22 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −19 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −18 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −17 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −16 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −15 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −12 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −11 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −10 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −9 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −8 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −7 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −6 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −5 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −4 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −3 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −2 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
| −1 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology… | Alma Lasers, Inc. | 2017 | — |
| 0 (this device) | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology… | Alma Lasers, Inc. | 2018 | — |
| +1 | K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022 | — |
| +2 | K251329 | Diode laser device (RF3120-BI) | Risu Medical Technology Co., Ltd. | 2025 | — |
| +2 | K230308 | Alma Harmony | Alma Lasers, Inc. | 2023 | — |
| +2 | K230371 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2023 | — |
| +1 | K201594 | Primelase Excellence | High Technology Products S.L.U | 2020 | — |
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 | 5 | 0 |
| 1990 | 7 | 0 |
| 1991 | 9 | 0 |
| 1992 | 6 | 0 |
| 1993 | 12 | 0 |
| 1994 | 27 | 0 |
| 1995 | 26 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 33 | 0 |
| 1999 | 29 | 0 |
| 2000 | 36 | 0 |
| 2001 | 36 | 0 |
| 2002 | 44 | 0 |
| 2003 | 48 | 0 |
| 2004 | 36 | 0 |
| 2005 | 31 | 0 |
| 2006 | 17 | 0 |
| 2007 | 17 | 0 |
| 2008 | 21 | 0 |
| 2009 | 12 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 4 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | K140009 | Soprano Ice Multi-Application & Multi-Technology PlatformSummary page 5…eating Class II Lamp, Infrared III. Predicate Devices [21 CFR 807.92(a) (3)] Type 510(k) # Trade Name Primary K140009, Modified Alma Lasers Soprano XL™ Family of K170626 Multi-Application and Multi-Technology… | 2014 |
| * | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology Platform…Summary page 5…ces [21 CFR 807.92(a) (3)] Type 510(k) # Trade Name Primary K140009, Modified Alma Lasers Soprano XL™ Family of K170626 Multi-Application and Multi-Technology Platforms [Soprano XL, Soprano XLi, and Soprano… | 2017 |
| † | K050779 | Cynergy Multiplex Laser | 2005 |
What descends from it? (22)
See all 227 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222064 | The Alma Soprano Titanium | 2022 | 14 |
| K201594 | Primelase Excellence | 2020 | 2 |
| K211722 | Laser treatment system , models Nyx plus, Grace plus, Nemesis, Ares | 2022 | 1 |
| K200118 | Diode Laser Therapy Device | 2020 | 1 |
| K252599 | Diode Laser Therapy Systems (WLA-02) | 2026 | 0 |
| K240474 | Multi-function Platform Systems (BL-M10) | 2024 | 0 |
| K222915 | Quadruple Laser System , Models : CPMT ARES , CPMT NEMESIS , CPMT NYX PLUS , CPMT GRACE… | 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 23 years and passes through 10 companies; a new generation was cleared every 10 months on median.
- 27 of the 564 ancestors have a recall of any class.
- Of its descendants, K222064 (Alma Lasers, Inc., 2022) has gone furthest, with 14 descendants of its own.
- 6 other devices also cite its predicate K140009.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 device is intended for use in dermatologic and general surgical procedures. TKH 6RSUDQR WULR 'LRGH /DVHU 0RGXOH is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano 5SJP Diode Laser Module include: Benign vascular and vascular dependent lesions removal. The indications for use for the Soprano1064nm Diode Laser Module include: The Hair Removal (HR) and Super Hair Removal (SHR) Mode are intended…
Read the full statement (454 words)
The device is intended for use in dermatologic and general surgical procedures.
TKH 6RSUDQR WULR 'LRGH /DVHU 0RGXOH is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano 5SJP Diode Laser Module include:
Benign vascular and vascular dependent lesions removal.
The indications for use for the Soprano1064nm Diode Laser Module include:
The Hair Removal (HR) and Super Hair Removal (SHR) Mode are 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.
Treatment of Pseudo folliculitis Barbae (PFB)
Use on all skin types (Fitzpatrick I-VI), including tanned skin.
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 are 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 are 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 are 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)
The Alma Lasers NIR Modules intended use is to emit energy in the near infrared (NIR) spectrum to provide topical heating.
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/K172193 · printed Nov 4, 2026
Cite this page
510(k) Report. “K172193: Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms [SopranoXL, SopranoXLi, SopranoICE and Soprano ICE Platinum] with Duo and Trio Diode Laser Modules., Soprano Duo and Trio Diode Laser Modules.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K172193
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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