510(k) · Cleared
ClearedYoulaser CO2 Laser
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 Apr 15, 2013 as substantially equivalent to K080496 (Lutronic Corporation, 2008) and 4 other predicates after a 146-day review. Its family tree reaches back 14 generations to 1992. 19 later devices descend from it.
- Decided
- Apr 15, 2013
- Review
- 146 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 14 generations to K910422 (1992). 156 ancestors in all, the oldest K820106 (1982). 19 later devices descend from it, 4 citing it directly.
- Root · 14 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 10 generations between
- 3 generations backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- 2 generations backK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- 1 generation backK091115 ECO2 Laser SystemLutronic Corporation · 2009
- This deviceK123573 Youlaser CO2 LaserQuanta System Spa · 2013
- Descendant · cites it directly · 14 of its ownK160312 Fraxis DuoIlooda Co,., Ltd. · 2016
- Descendant · 2 generations on · 10 of its ownK170325 Secret RFIlooda Co,., Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK210084 SilkroHironic Co., Ltd. · 2022
- Descendant · 3 generations on · 3 of its ownK180654 PINXEL-RF systemRohrer Aesthetics, LLC · 2018
- Descendant · 2 generations on · 2 of its ownK172096 FraxisIlooda Co,., Ltd. · 2017
Show all 14 generations
- Root · 14 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 13 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 12 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 11 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 10 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 9 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 8 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 7 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 6 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 5 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 4 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 3 generations backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- 2 generations backK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- 1 generation backK091115 ECO2 Laser SystemLutronic Corporation · 2009
- This deviceK123573 Youlaser CO2 LaserQuanta System Spa · 2013
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K160312Fraxis DuoIlooda Co,., Ltd. · 2016 · cites it directly14descendants
- K170325Secret RFIlooda Co,., Ltd. · 2017 · 2 generations on10descendants
- K210084SilkroHironic Co., Ltd. · 2022 · 3 generations on3descendants
- K180654PINXEL-RF systemRohrer Aesthetics, LLC · 2018 · 3 generations on3descendants
- K172096FraxisIlooda Co,., Ltd. · 2017 · 2 generations on2descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −14 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −13 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −12 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −11 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −10 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −9 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −8 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −7 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −6 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −5 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −4 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −3 | K071051 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
| −2 | K080915 | Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories | Reliant Technologies, Inc. | 2008 | — |
| −1 | K091115 | ECO2 Laser System | Lutronic Corporation | 2009 | — |
| 0 (this device) | K123573 | Youlaser CO2 Laser | Quanta System Spa | 2013 | — |
| +1 | K160312 | Fraxis Duo | Ilooda Co,., Ltd. | 2016 | — |
| +2 | K170325 | Secret RF | Ilooda Co,., Ltd. | 2017 | — |
| +3 | K210084 | Silkro | Hironic Co., Ltd. | 2022 | — |
| +3 | K180654 | PINXEL-RF system | Rohrer Aesthetics, LLC | 2018 | — |
| +2 | K172096 | Fraxis | Ilooda Co,., Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 2 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1993 | 5 | 0 |
| 1994 | 13 | 0 |
| 1995 | 10 | 0 |
| 1996 | 13 | 0 |
| 1997 | 10 | 0 |
| 1998 | 9 | 0 |
| 1999 | 7 | 0 |
| 2000 | 12 | 0 |
| 2001 | 10 | 0 |
| 2002 | 15 | 0 |
| 2003 | 13 | 0 |
| 2004 | 4 | 0 |
| 2005 | 3 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 2 | 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? (5)
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 |
|---|---|---|---|
| * | K080496 | Mosaic ECO2 Laser SystemSummary page 1…e YOULASER 002 Laser System is claimed to be substantially equivalent to the following legally marketed predicate devices: Lutronic Corp - MOSAIC e C02 (K080496) Lutronic Corp - MOSAIC e C02 (K091115) Lasering Sri - SLIM Evolution Family (K063001)… | 2008 |
| * | K091115 | ECO2 Laser SystemSummary page 1…lly equivalent to the following legally marketed predicate devices: Lutronic Corp - MOSAIC e C02 (K080496) Lutronic Corp - MOSAIC e C02 (K091115) Lasering Sri - SLIM Evolution Family (K063001) Lasering Sri - SLIM Evolution 11Family (K1 10984)… | 2009 |
| * | K063001 | Slim Evolution Family of CO2 Lasers and Delivery Device AccessoriesSummary page 1…ces: Lutronic Corp - MOSAIC e C02 (K080496) Lutronic Corp - MOSAIC e C02 (K091115) Lasering Sri - SLIM Evolution Family (K063001) Lasering Sri - SLIM Evolution 11Family (K1 10984) EI.En S.p.A - Smart C02 Laser System (K072159)… | 2007 |
| * | K110984 | Slim E30 II CO2 LaserSummary page 1…Lutronic Corp - MOSAIC e C02 (K091115) Lasering Sri - SLIM Evolution Family (K063001) Lasering Sri - SLIM Evolution 11Family (K1 10984) EI.En S.p.A - Smart C02 Laser System (K072159) 1/3 Per… | 2011 |
| * | K072159 | Smart CO2 (Smartxide, Smart US20D) with Dot ScannerSummary page 1…Lasering Sri - SLIM Evolution Family (K063001) Lasering Sri - SLIM Evolution 11Family (K1 10984) EI.En S.p.A - Smart C02 Laser System (K072159) 1/3 Performance Standards: There are no mandatory performance standard… | 2007 |
What descends from it? (19)
See all 194 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 21 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 156 ancestors have a recall of any class.
- Of its descendants, K160312 (Ilooda Co,., Ltd., 2016) has gone furthest, with 14 descendants of its own.
- 3 other devices also cite its predicate K080496.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
YOULASER C02 laser when used in traditional, non fractionated mode is indicated for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER C02 laser when used in fractionated mode (dot scanner) is indicated only…
Read the full statement (126 words)
YOULASER C02 laser when used in traditional, non fractionated mode is indicated for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery.
YOULASER C02 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacing.
YOULASER 002 laser when used in traditional, non fractionated mode is indicated for: incision, excision, ablation, vaporization and coagulation of body soft tissues including intraoral tissues, in medical specialties including aesthetic (dermatology and plastic surgery), otorhinolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery.
YOULASER 002 laser when used in fractionated mode (dot scanner) is indicated only for ablative skin resurfacihg.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123573 · printed Nov 4, 2026
Cite this page
510(k) Report. “K123573: Youlaser CO2 Laser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K123573
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