510(k) · Cleared
ClearedThe Alma Hybrid Laser System
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 Jul 2, 2021 as substantially equivalent to K103501 (Alma Lasers, Inc., 2011) and 1 other predicate after a 221-day review. Its family tree reaches back 20 generations to 1992. 5 later devices descend from it.
- Decided
- Jul 2, 2021
- Review
- 221 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 20 generations to K910422 (1992). 327 ancestors in all, the oldest K800617 (1980). 5 later devices descend from it, 4 citing it directly.
- Root · 20 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 16 generations between
- 3 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 2 generations backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- 1 generation backK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- This deviceK203441 The Alma Hybrid Laser SystemAlma Lasers, Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK233024 Alma HarmonyAlma Lasers, Inc. · 2024
- Descendant · cites it directly · 1 of its ownK222221 Deka HelixEl.En Electronic Engineering Spa · 2023
- Descendant · 2 generations on · 0 of its ownK252561 BTL-754FFBTL Industries, Inc. · 2026
- Descendant · cites it directly · 0 of its ownK251230 The Alma Hybrid Laser SystemAlma Lasers, Inc. · 2025
- Descendant · cites it directly · 0 of its ownK241092 Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa · 2024
Show all 20 generations
- Root · 20 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 19 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 18 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 17 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 16 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 15 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 14 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 13 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 12 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 11 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 10 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 9 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 8 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 7 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 6 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 5 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 4 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 3 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 2 generations backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- 1 generation backK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- This deviceK203441 The Alma Hybrid Laser SystemAlma Lasers, Ltd. · 2021
Most influential descendants
Showing 5 of 5 · See all- K233024Alma HarmonyAlma Lasers, Inc. · 2024 · cites it directly1descendant
- K222221Deka HelixEl.En Electronic Engineering Spa · 2023 · cites it directly1descendant
- K252561BTL-754FFBTL Industries, Inc. · 2026 · 2 generations on0descendants
- K251230The Alma Hybrid Laser SystemAlma Lasers, Inc. · 2025 · cites it directly0descendants
- K241092Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −20 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −19 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −18 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −17 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −16 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −15 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −14 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −13 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −12 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −11 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −10 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −9 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −8 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −7 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −6 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −5 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −4 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| −3 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| −2 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| −1 | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
| 0 (this device) | K203441 | The Alma Hybrid Laser System | Alma Lasers, Ltd. | 2021 | — |
| +1 | K233024 | Alma Harmony | Alma Lasers, Inc. | 2024 | — |
| +1 | K222221 | Deka Helix | El.En Electronic Engineering Spa | 2023 | — |
| +2 | K252561 | BTL-754FF | BTL Industries, Inc. | 2026 | — |
| +1 | K251230 | The Alma Hybrid Laser System | Alma Lasers, Inc. | 2025 | — |
| +1 | K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT | Quanta System Spa | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 3 | 0 |
| 1989 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 7 | 0 |
| 1992 | 2 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 17 | 0 |
| 1996 | 22 | 0 |
| 1997 | 24 | 0 |
| 1998 | 19 | 0 |
| 1999 | 13 | 0 |
| 2000 | 26 | 0 |
| 2001 | 27 | 0 |
| 2002 | 32 | 0 |
| 2003 | 30 | 0 |
| 2004 | 18 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 8 | 0 |
| 2008 | 5 | 0 |
| 2009 | 4 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 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 |
|---|---|---|---|
| * | K103501 | Alma Lasers Pixel CO2 Laser System, Delivery Device and AccessoriesSummary page 5…Product Code Primary K103501 Alma Lasers Pixel CO2 Laser System GEX Reference K080463 Alma Lasers System… | 2011 |
| * | K170060 | M22 and ResurFx SystemsSummary page 5…CO2 Laser System GEX Reference K080463 Alma Lasers System GEX Secondary K170060 M22 And ResurFx Systems GEX Premarket Notification, Traditional 510(k)… | 2017 |
| † | K080463 | Alma Lasers Thermoxel CO2 Laser System and Delivery Device Accessories | 2008 |
What descends from it? (5)
4 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 29 years and passes through 10 companies; a new generation was cleared every 1.1 years on median.
- 16 of the 327 ancestors have a recall of any class.
- Of its descendants, K233024 (Alma Lasers, Inc., 2024) has gone furthest, with 1 descendant of its own.
- 4 other devices also cite its predicate K103501.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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 Alma Hybrid Laser System, Delivery Devices, Applicators and Accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery). HyLight-CO2 The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 nm is cleared for use for the particular indications as follows: Dermatology…
Read the full statement (236 words)
The Alma Hybrid Laser System, Delivery Devices, Applicators and Accessories are intended for use in surgical applications requiring the ablation, vaporization, excision, incision, and coagulation of soft tissue in medical specialties including: aesthetic surgery (dermatology and plastic surgery).
HyLight-CO2
The Alma Hybrid CO2 non-fractional applicator, with wavelength of 10600 nm is cleared for use for the particular indications as follows:
Dermatology & Plastic Surgery
The ablation, vaporization, excision, incision, and coagulation of soft tissue in dermatology and plastic surgery in the performance of:
* laser skin resurfacing
* laser derm-abrasion
* laser burn debridement.
Laser skin resurfacing (ablation and/or vaporization) of soft tissue for the reduction, removal, and/or treatment of: warts, acne scars, nevi epidermal, syringoma. Vaporization/coagulation of warts.
Pixel
The Alma Hybrid Pixel CO2 fractional applicator, with wavelength of 10600 nm is indicated for: The ablation, vaporization, and coagulation of soft tissue in dermatology and plastic surgery in the performance of skin resurfacing.
ProScan
The Alma Hybrid ProScan CO2 fractional applicator, with wavelength of 10600 nm is indicated for:
» Laser skin resurfacing (ablation and/or vaporization) of soft tissue.
The Alma Hybrid ProScan 1570nm fractional applicator, with wavelength of 1570 nm, is indicated for:
» Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
The Alma Hybrid ProScan CO2 &1570nm fractional applicator, with wavelengths of 10600 nm & 1570nm is indicated for laser skin resurfacing (ablation and/or vaporization) of soft tissue.
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/K203441 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203441: The Alma Hybrid Laser System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203441
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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