510(k) · Cleared
ClearedYoulaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Quanta System Spa · GEX Powered Laser Surgical Instrument
Cleared on Oct 10, 2024 as substantially equivalent to K203441 (Alma Lasers, Ltd., 2021) and 2 other predicates after a 171-day review. Its family tree reaches back 22 generations to 1992.
- Decided
- Oct 10, 2024
- Review
- 171 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 22 generations to K910422 (1992). 336 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 22 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 18 generations between
- 3 generations backK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- 2 generations backK203441 The Alma Hybrid Laser SystemAlma Lasers, Ltd. · 2021
- 1 generation backK222221 Deka HelixEl.En Electronic Engineering Spa · 2023
- This deviceK241092 Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa · 2024
Show all 22 generations
- Root · 22 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 21 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 20 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 19 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 18 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 17 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 16 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 15 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 14 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 13 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 12 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 11 generations backK070284 Fralex SR 1500 Laser System (Fralex II SR Laser System)Reliant Technologies, Inc. · 2007
- 10 generations backK080244 Palomar Lux 1540 HandpiecePalomar Medical Products, Inc. · 2008
- 9 generations backK083900 Erbium Fractional HandpiecePalomar Medical Products, Inc. · 2009
- 8 generations backK100270 Artisan Aesthetic SystemPalomar Medical Technologies, Inc. · 2010
- 7 generations backK101506 LUX1540, LUX1440 & LUX2940 Laser HandpiecesPalomar Medical Technologies, Inc. · 2010
- 6 generations backK110907 Palomar Icon (TM) Aesthetic SystemPalomar Medical Technologies, Inc. · 2011
- 5 generations backK130028 Resurfx 1565NM Laser ModuleLumenis, Ltd. · 2013
- 4 generations backK142860 Lumenis M22 SystemLumenis, Ltd. · 2015 · Recalled
- 3 generations backK170060 M22 and ResurFx SystemsLumenis, Ltd. · 2017
- 2 generations backK203441 The Alma Hybrid Laser SystemAlma Lasers, Ltd. · 2021
- 1 generation backK222221 Deka HelixEl.En Electronic Engineering Spa · 2023
- This deviceK241092 Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −21 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −20 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −19 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −18 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −17 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −16 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −15 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −14 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −13 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −12 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −11 | K070284 | Fralex SR 1500 Laser System (Fralex II SR Laser System) | Reliant Technologies, Inc. | 2007 | — |
| −10 | K080244 | Palomar Lux 1540 Handpiece | Palomar Medical Products, Inc. | 2008 | — |
| −9 | K083900 | Erbium Fractional Handpiece | Palomar Medical Products, Inc. | 2009 | — |
| −8 | K100270 | Artisan Aesthetic System | Palomar Medical Technologies, Inc. | 2010 | — |
| −7 | K101506 | LUX1540, LUX1440 & LUX2940 Laser Handpieces | Palomar Medical Technologies, Inc. | 2010 | — |
| −6 | K110907 | Palomar Icon (TM) Aesthetic System | Palomar Medical Technologies, Inc. | 2011 | — |
| −5 | K130028 | Resurfx 1565NM Laser Module | Lumenis, Ltd. | 2013 | — |
| −4 | K142860 | Lumenis M22 System | Lumenis, Ltd. | 2015 | 1 |
| −3 | K170060 | M22 and ResurFx Systems | Lumenis, Ltd. | 2017 | — |
| −2 | K203441 | The Alma Hybrid Laser System | Alma Lasers, Ltd. | 2021 | — |
| −1 | K222221 | Deka Helix | El.En Electronic Engineering Spa | 2023 | — |
| 0 (this device) | 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 | 31 | 0 |
| 2004 | 18 | 0 |
| 2005 | 8 | 0 |
| 2006 | 5 | 0 |
| 2007 | 9 | 0 |
| 2008 | 6 | 0 |
| 2009 | 5 | 0 |
| 2011 | 2 | 0 |
| 2013 | 1 | 0 |
| 2018 | 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? (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 |
|---|---|---|---|
| * | K203441 | The Alma Hybrid Laser SystemSummary page 6…plastic surgery and in dermatology. Regulation Number: 21 CFR 878.4810 Product Code: GEX Predicate devices: The Alma Hybrid Laser System (K203441), Deka Helix (K222221), Youlaser CO2 (K182669) Rev02 03/10/2024 1 Abbreviations… | 2021 |
| * | K222221 | Deka HelixSummary page 6…Regulation Number: 21 CFR 878.4810 Product Code: GEX Predicate devices: The Alma Hybrid Laser System (K203441), Deka Helix (K222221), Youlaser CO2 (K182669) Rev02 03/10/2024 1 Abbreviations FW= firmware GUI= graphical user interf… | 2023 |
| * | K182669 | Youlaser CO2Summary page 6…21 CFR 878.4810 Product Code: GEX Predicate devices: The Alma Hybrid Laser System (K203441), Deka Helix (K222221), Youlaser CO2 (K182669) Rev02 03/10/2024 1 Abbreviations FW= firmware GUI= graphical user interface SW= software… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 12 companies; a new generation was cleared every 1.2 years on median.
- 16 of the 336 ancestors have a recall of any class.
- 3 other devices also cite its predicate K203441.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Youlaser PRIME family laser devices (Youlaser PRIME, Youlaser PRIME CO2, Youlaser PRIME MT) 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). Surgical Handpieces Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in…
Read the full statement (232 words)
The Youlaser PRIME family laser devices (Youlaser PRIME, Youlaser PRIME CO2, Youlaser PRIME MT) 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).
Surgical Handpieces
Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with surgical handpieces are indicated 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.
OptiScan PRIME Scanner
Youlaser PRIME CO2, Youlaser PRIME and Youlaser PRIME MT with a wavelength of 10600nm used in combination with OptiScan PRIME scanner are indicated for:
*Laser skin resurfacing (ablation and/or vaporization) of soft tissue
Youlaser PRIME and Youlaser PRIME MT with wavelength of 1550nm used in combination with OptiScan PRIME scanner, are indicated for:
» Use in dermatological procedures requiring fractional skin resurfacing and coagulation of soft tissue
Youlaser PRIME MT with wavelengths of 10600nm & 1550nm used in combination with OptiScan PRIME 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/K241092 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241092: Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241092
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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