510(k) · Cleared
ClearedThe Alma Soprano Titanium
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 Oct 12, 2022 as substantially equivalent to K172193 (Alma Lasers, Inc., 2018) after a 91-day review. Its family tree reaches back 24 generations to 1995. 14 later devices descend from it.
- Decided
- Oct 12, 2022
- Review
- 91 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 24 generations to K943450 (1995). 565 ancestors in all, the oldest K771218 (1978). 14 later devices descend from it, 9 citing it directly.
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 20 generations between
- 3 generations backK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- 2 generations backK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- 1 generation backK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- This deviceK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022
- Descendant · cites it directly · 2 of its ownK251329 Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd. · 2025
- Descendant · cites it directly · 2 of its ownK230308 Alma HarmonyAlma Lasers, Inc. · 2023
- Descendant · cites it directly · 2 of its ownK230371 The Alma Soprano TitaniumAlma Lasers, Inc. · 2023
- Descendant · 2 generations on · 1 of its ownK233024 Alma HarmonyAlma Lasers, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK222862 SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd. · 2023
Show all 24 generations
- Root · 24 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 23 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 22 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 21 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 20 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 19 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 18 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 17 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 16 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 15 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 14 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 13 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 12 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 11 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 10 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 9 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 8 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 7 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 6 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 5 generations backK132806 Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser HandpieceFotona D.D. · 2014
- 4 generations backK143723 SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP SpectroFotona D.D. · 2015
- 3 generations backK153671 Family of CoolGlide Aesthetic LasersCutera, Inc. · 2016
- 2 generations backK170626 Modified Alma Lasers Soprano XL Family of Multi-Application &…Alma Lasers, Inc. · 2017
- 1 generation backK172193 Modified Alma Lasers Soprano XL™ Family ofMulti-Application &…Alma Lasers, Inc. · 2018
- This deviceK222064 The Alma Soprano TitaniumAlma Lasers, Inc. · 2022
Showing 5 of 14 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 14 · See all- K251329Diode laser device (RF3120-BI)Risu Medical Technology Co., Ltd. · 2025 · cites it directly2descendants
- K230308Alma HarmonyAlma Lasers, Inc. · 2023 · cites it directly2descendants
- K230371The Alma Soprano TitaniumAlma Lasers, Inc. · 2023 · cites it directly2descendants
- K233024Alma HarmonyAlma Lasers, Inc. · 2024 · 2 generations on1descendant
- K222862SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWCLotuxs Medtech (Suzhou) Co., Ltd. · 2023 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −24 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −23 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −22 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −21 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −20 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −19 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −18 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −17 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −16 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −15 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −14 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −13 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −12 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −11 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −10 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −9 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −8 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −7 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −6 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −5 | K132806 | Fotona F-22 Laser Handpiece (F-Runner), Fotona FS-01 Laser Handpiece | Fotona D.D. | 2014 | — |
| −4 | K143723 | SP Dynamis, SP Spectro, XS Dynamis, XP Dynamis, XP Spectro | Fotona D.D. | 2015 | — |
| −3 | K153671 | Family of CoolGlide Aesthetic Lasers | Cutera, Inc. | 2016 | — |
| −2 | K170626 | Modified Alma Lasers Soprano XL Family of Multi-Application & Multi-Technology… | Alma Lasers, Inc. | 2017 | — |
| −1 | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology… | Alma Lasers, Inc. | 2018 | — |
| 0 (this device) | K222064 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2022 | — |
| +1 | K251329 | Diode laser device (RF3120-BI) | Risu Medical Technology Co., Ltd. | 2025 | — |
| +1 | K230308 | Alma Harmony | Alma Lasers, Inc. | 2023 | — |
| +1 | K230371 | The Alma Soprano Titanium | Alma Lasers, Inc. | 2023 | — |
| +2 | K233024 | Alma Harmony | Alma Lasers, Inc. | 2024 | — |
| +1 | K222862 | SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC | Lotuxs Medtech (Suzhou) Co., Ltd. | 2023 | — |
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 |
|---|---|---|
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 3 | 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 K202503 Chromescore 31.9 · 26 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K172193 | Modified Alma Lasers Soprano XL™ Family ofMulti-Application & Multi-Technology Platforms…Summary page 5…Product Code Primary K172193 Soprano Ice Platinum GEX IV. Device Description [21 CFR 807.92(a) (4)]… | 2018 |
What descends from it? (14)
See all 149 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251329 | Diode laser device (RF3120-BI) | 2025 | 2 |
| K230308 | Alma Harmony | 2023 | 2 |
| K230371 | The Alma Soprano Titanium | 2023 | 2 |
| K222862 | SILKPRO Titanium Diode Laser System SILKPRO-S20S-TWC | 2023 | 1 |
| K252599 | Diode Laser Therapy Systems (WLA-02) | 2026 | 0 |
| K242859 | VEGA | 2025 | 0 |
| K250206 | Diode laser system (Night Universe; Predator) | 2025 | 0 |
| K240611 | IVYLASER Diode laser hair removal system (IVY-HR-Alloy) | 2024 | 0 |
| K230580 | Diode Laser System | 2023 | 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 27 years and passes through 10 companies; a new generation was cleared every 11 months on median.
- 27 of the 565 ancestors have a recall of any class.
- Of its descendants, K251329 (Risu Medical Technology Co., Ltd., 2025) has gone furthest, with 2 descendants of its own.
- 6 other devices also cite its predicate K172193.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include: The Super Hair Removal (SHR) Mode is intended for temporary hair reduction. The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser HR module include: Benign…
Read the full statement (341 words)
The Soprano Titanium diode laser module is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser module include:
The Super Hair Removal (SHR) Mode is intended for temporary hair reduction.
The Soprano Trio diode laser module HR mode is intended for use in dermatology procedures requiring coagulation. The indications for use for the Soprano Trio diode laser HR module include: Benign vascular and vascular dependent lesions.
810nm Applicator
Soprano Titanium 810 nm applicator intended use and indications for use:
The indications for use for the §10nm Modified Diode Laser Module 2 cm?2 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)
755nm applicator
Soprano Titanium 755 nm applicator intended use and indications for use:
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.
» Use on all skin types (Fitzpatrick I-VI), including tanned skin.(HR, SHR Modes)
NIR Applicator
NIR Applicator intended use and indications for use
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222064 · printed Nov 5, 2026
Cite this page
510(k) Report. “K222064: The Alma Soprano Titanium.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K222064
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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