510(k) · Cleared
ClearedModified Alma Lasers Family of Soprano XL Multi-Application Platmforms
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 Sep 28, 2010 as substantially equivalent to K052874 (Msq (M2), Ltd., 2005) and 2 other predicates after a 7-day review. Its family tree reaches back 9 generations to 1992. 124 later devices descend from it.
- Decided
- Sep 28, 2010
- Review
- 7 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K910422 (1992). 57 ancestors in all, the oldest K871179 (1987). 124 later devices descend from it, 4 citing it directly.
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 5 generations between
- 3 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 2 generations backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- 1 generation backK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- This deviceK102716 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
- Descendant · 3 generations on · 40 of its ownK162659 Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 2017
Show all 9 generations
- Root · 9 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 8 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 7 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 6 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 5 generations backK013366 Prolite Pulsed Light System for the Removal of Unwanted HairMedical Bio Care Sweden AB · 2002
- 4 generations backK022568 Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted…Medical Bio Care Sweden AB · 2002
- 3 generations backK023954 Altus Medical Coolglide Laser Systems and AccessoriesAltus Medical, Inc. · 2003
- 2 generations backK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- 1 generation backK080318 Alma Laser Nir ModuleAlma Lasers, Ltd. · 2008
- This deviceK102716 Modified Alma Lasers Family of Soprano XL Multi-Application PlatmformsAlma Lasers, Inc. · 2010
Showing 5 of 124 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 124 · See all- 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
- K162659Diode Laser Hair Removal SystemShandong Huamei Technology Co., Ltd. · 2017 · 3 generations on40descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −8 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −7 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −6 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −5 | K013366 | Prolite Pulsed Light System for the Removal of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −4 | K022568 | Prolite/Plasmalite MPX Pulsed Light System for Treatment of Unwanted Hair | Medical Bio Care Sweden AB | 2002 | — |
| −3 | K023954 | Altus Medical Coolglide Laser Systems and Accessories | Altus Medical, Inc. | 2003 | — |
| −2 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| −1 | K080318 | Alma Laser Nir Module | Alma Lasers, Ltd. | 2008 | — |
| 0 (this device) | 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 | — |
| +3 | K162659 | Diode Laser Hair Removal System | Shandong Huamei Technology Co., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 2 | 0 |
| 1988 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1997 | 5 | 0 |
| 1998 | 3 | 0 |
| 1999 | 3 | 0 |
| 2000 | 7 | 0 |
| 2001 | 5 | 0 |
| 2002 | 5 | 0 |
| 2003 | 4 | 0 |
| 2004 | 1 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K052874 | Soprano Hair Removal Diode LaserSummary page 1…Powered; GEX Lamp, Infrared, Therapeutic Heating * Predicate Devices * Soprano Hair Removal Diode Laser system (K052874), cleared 11/22/2005, * Alma Lasers Soprano XL Multi-Application Platform (K083848), cleared 04/14/2009 * Alma… | 2005 |
| * | K083848 | Alma Lasers Soprano XL Multi-Application PlatformSummary page 1…ing * Predicate Devices * Soprano Hair Removal Diode Laser system (K052874), cleared 11/22/2005, * Alma Lasers Soprano XL Multi-Application Platform (K083848), cleared 04/14/2009 * Alma Lasers NIR Module (K0803 18), cleared 03/07/2008, * Product Description The Al… | 2009 |
| * | K080318 | Alma Laser Nir ModuleSummary page 1…Laser system (K052874), cleared 11/22/2005, * Alma Lasers Soprano XL Multi-Application Platform (K083848), cleared 04/14/2009 * Alma Lasers NIR Module (K0803 18), cleared 03/07/2008, * Product Description The Alma Lasers Soprano XLi system is a multi-application, multi-techno… | 2008 |
What descends from it? (124)
See all 1244 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 18 years and passes through 8 companies; a new generation was cleared every 1.6 years on median.
- 3 of the 57 ancestors have a recall of any class.
- Of its descendants, K112031 (Alma Lasers, Inc., 2011) has gone furthest, with 118 descendants of its own.
- 1 other device also cites its predicate K052874.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 Family of SOPRANO XLTM Multi-Application Platforms [Soprano XL, Soprano XLi] is intended for use in dermatologic and general surgical procedures. The Alma Lasers Family of SOPRANO XLTM Multi-Application Platforms [Soprano XL, Soprano XLi] includes a Diode Laser Module and an optional NIR Module. The Diode Laser Module: The HIR Mode is intended for hair removal, permanent hair reduction. The LaserBlanche Mode is intended for the…
Read the full statement (179 words)
The Modified Alma Lasers Family of SOPRANO XLTM Multi-Application Platforms [Soprano XL, Soprano XLi] is intended for use in dermatologic and general surgical procedures.
The Alma Lasers Family of SOPRANO XLTM Multi-Application Platforms [Soprano XL, Soprano XLi] includes a Diode Laser Module and an optional NIR Module.
The Diode Laser Module:
The HIR 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 Modified Alma Lasers Family of Soprano™ Diode Laser Systems [Soprano XL, Soprano XLi] 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/K102716 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102716: Modified Alma Lasers Family of Soprano XL Multi-Application Platmforms.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102716
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