510(k) · Cleared
ClearedAlma Lasers Soprano XL Multi-Application 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 Apr 14, 2009 as substantially equivalent to K001746 (Coherent Star, 2000) and 5 other predicates after a 111-day review. Its family tree reaches back 3 generations to 2000. 125 later devices descend from it.
- Decided
- Apr 14, 2009
- Review
- 111 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 3 generations to K001746 (2000). 7 ancestors in all. 125 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK001746 Lightsheer Pulsed Diode Array Laser System (Family of Products)Coherent Star · 2000
- 2 generations backK030805 Mythos 500Msq (M2), Ltd. · 2003
- 1 generation backK052874 Soprano Hair Removal Diode LaserMsq (M2), Ltd. · 2005
- This deviceK083848 Alma Lasers Soprano XL Multi-Application PlatformAlma Lasers, Ltd. · 2009
- Descendant · cites it directly · 124 of its ownK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
- Descendant · cites it directly · 118 of its ownK112031 Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for…Alma Lasers, Inc. · 2011
- Descendant · cites it directly · 57 of its ownK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- Descendant · 2 generations on · 53 of its ownK123483 Diode LaserBeijing Syntech Laser CO., LTD. · 2013
- Descendant · 3 generations on · 48 of its ownK141973 Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd. · 2014
Showing 5 of 125 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 125 · See all- K102716Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010 · cites it directly124descendants
- K112031Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with the Family…Alma Lasers, Inc. · 2011 · cites it directly118descendants
- K140009Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014 · cites it directly57descendants
- K123483Diode LaserBeijing Syntech Laser CO., LTD. · 2013 · 2 generations on53descendants
- K141973Diode Laser Hair Removal SystemBeijing Anchorfree Technology Co., Ltd. · 2014 · 3 generations on48descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001746 | Lightsheer Pulsed Diode Array Laser System (Family of Products) | Coherent Star | 2000 | — |
| −2 | K030805 | Mythos 500 | Msq (M2), Ltd. | 2003 | — |
| −1 | K052874 | Soprano Hair Removal Diode Laser | Msq (M2), Ltd. | 2005 | — |
| 0 (this device) | K083848 | Alma Lasers Soprano XL Multi-Application Platform | Alma Lasers, Ltd. | 2009 | — |
| +1 | K102716 | Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms | Alma Lasers, Inc. | 2010 | — |
| +1 | K112031 | Alma Lasers Modified Diode Laser Module with SHR Treatment Mode for Use with… | Alma Lasers, Inc. | 2011 | — |
| +1 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| +2 | K123483 | Diode Laser | Beijing Syntech Laser CO., LTD. | 2013 | — |
| +3 | K141973 | Diode Laser Hair Removal System | Beijing Anchorfree Technology Co., Ltd. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2015 | 6 | 0 |
| 2016 | 5 | 0 |
| 2017 | 3 | 0 |
| 2018 | 7 | 0 |
| 2019 | 9 | 0 |
| 2020 | 13 | 0 |
| 2021 | 11 | 0 |
| 2022 | 15 | 0 |
| 2023 | 10 | 0 |
| 2024 | 13 | 0 |
| 2025 | 15 | 0 |
| 2026 | 9 | 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? (6)
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 |
|---|---|---|---|
| * | K001746 | Lightsheer Pulsed Diode Array Laser System (Family of Products) | 2000 |
| * | K003614 | Lightsheer Pulsed Diode Array Laser SystemSummary page 1…nt, Surgical, Powered III. Predicate Devices * KO01746 - LightSheer Pulsed Diode Array Laser System Lumenis, Inc. (formerly Coherent Star) *K003614 - LightSheer Pulsed Diode Array Laser System Lumenis, Inc. (formerly Coherent Star) *K013028 - Palomar SLPTM 1000… | 2001 |
| * | K013028 | Palomar SLP 1000Summary page 1…stem Lumenis, Inc. (formerly Coherent Star) *K003614 - LightSheer Pulsed Diode Array Laser System Lumenis, Inc. (formerly Coherent Star) *K013028 - Palomar SLPTM 1000- Palomar Medical Technologies, Inc. * K050900 - MeDioStar XL - Asclepion Laser technologies, GmbH.… | 2001 |
| * | K050900 | Mediostar XTSummary page 1…htSheer Pulsed Diode Array Laser System Lumenis, Inc. (formerly Coherent Star) *K013028 - Palomar SLPTM 1000- Palomar Medical Technologies, Inc. * K050900 - MeDioStar XL - Asclepion Laser technologies, GmbH. *K052874 - Soprano Hair Removal Diode Laser System - Alma Lasers, Ltd… | 2005 |
| * | K052874 | Soprano Hair Removal Diode LaserSummary page 1…Coherent Star) *K013028 - Palomar SLPTM 1000- Palomar Medical Technologies, Inc. * K050900 - MeDioStar XL - Asclepion Laser technologies, GmbH. *K052874 - Soprano Hair Removal Diode Laser System - Alma Lasers, Ltd. (formerly MSq., Ltd.) * K053628 - LightSheer DuetTM… | 2005 |
| * | K053628 | Lightsheer Duet Laser SystemSummary page 1…MeDioStar XL - Asclepion Laser technologies, GmbH. *K052874 - Soprano Hair Removal Diode Laser System - Alma Lasers, Ltd. (formerly MSq., Ltd.) * K053628 - LightSheer DuetTM Laser System - Lumenis, Inc. IV. Product Description The Soprano XL Multi-Application Platfo… | 2006 |
What descends from it? (125)
See all 1253 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 9 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K102716 (Alma Lasers, Inc., 2010) has gone furthest, with 124 descendants of its own.
- 8 other devices also cite its predicate K001746.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 XLTM Multi-Application Platform includes a Diode Laser Module and an optional NIR Module. The Diode Laser Module: The HR Mode is intended for hair removal, permanent hair reduction. The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions. The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of elevating the tissue temperature for the temporary relief…
Read the full statement (138 words)
The SOPRANO XLTM Multi-Application Platform includes a Diode Laser Module and an optional NIR Module.
The Diode Laser Module:
The HR Mode is intended for hair removal, permanent hair reduction.
The LaserBlanche Mode is intended for the treatment of benign vascular and pigmented lesions.
The NIR Module is intended to emit energy in the infrared spectrum to provide topical heating for the purpose of 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.
The SOPRANO XLTM Multi-Application Platform is intended for use on all skin types (Fitzpatrick skin types I-VI), including tanned skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083848 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083848: Alma Lasers Soprano XL Multi-Application Platform.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083848
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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