510(k) · Cleared
ClearedYoulaser CO2
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 17, 2018 as substantially equivalent to K123573 (Quanta System Spa, 2013) after a 22-day review. Its family tree reaches back 15 generations to 1992. 1 later device descends from it.
- Decided
- Oct 17, 2018
- Review
- 22 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 15 generations to K910422 (1992). 157 ancestors in all, the oldest K820106 (1982). 1 later device descends from it, 1 citing it directly.
- Root · 15 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 11 generations between
- 3 generations backK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- 2 generations backK091115 ECO2 Laser SystemLutronic Corporation · 2009
- 1 generation backK123573 Youlaser CO2 LaserQuanta System Spa · 2013
- This deviceK182669 Youlaser CO2Quanta System Spa · 2018
- Descendant · cites it directly · 0 of its ownK241092 Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MTQuanta System Spa · 2024
Show all 15 generations
- Root · 15 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 14 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 13 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 12 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 11 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 10 generations backK014040 Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models…Altus Medical, Inc. · 2002
- 9 generations backK023193 Candela Gentle Yag Laser SystemCandela Corp. · 2002
- 8 generations backK033172 Candela Gentleyag Family of Laser SystemsCandela Corp. · 2003
- 7 generations backK040617 Reliant Laser System IIReliant Technologies, Inc. · 2004
- 6 generations backK060310 Fraxel II SR Laser System and AccessoriesReliant Technologies, Inc. · 2006
- 5 generations backK062303 Fraxel II SR Laser SystemReliant Technologies, Inc. · 2007
- 4 generations backK071051 Fraxel Iii SR Laser System and AccessoriesReliant Technologies, Inc. · 2007
- 3 generations backK080915 Fraxel RE:Pair (Fraxel Iii SR) Laser System and AccessoriesReliant Technologies, Inc. · 2008
- 2 generations backK091115 ECO2 Laser SystemLutronic Corporation · 2009
- 1 generation backK123573 Youlaser CO2 LaserQuanta System Spa · 2013
- This deviceK182669 Youlaser CO2Quanta System Spa · 2018
Most influential descendants
Showing 1 of 1 · See all- 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 |
|---|---|---|---|---|---|
| −15 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −14 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −13 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −12 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −11 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −10 | K014040 | Family of Altus Medical Modified Coolglide Aesthetic Lasers, Models Coolglide… | Altus Medical, Inc. | 2002 | — |
| −9 | K023193 | Candela Gentle Yag Laser System | Candela Corp. | 2002 | — |
| −8 | K033172 | Candela Gentleyag Family of Laser Systems | Candela Corp. | 2003 | — |
| −7 | K040617 | Reliant Laser System II | Reliant Technologies, Inc. | 2004 | — |
| −6 | K060310 | Fraxel II SR Laser System and Accessories | Reliant Technologies, Inc. | 2006 | — |
| −5 | K062303 | Fraxel II SR Laser System | Reliant Technologies, Inc. | 2007 | — |
| −4 | K071051 | Fraxel Iii SR Laser System and Accessories | Reliant Technologies, Inc. | 2007 | — |
| −3 | K080915 | Fraxel RE:Pair (Fraxel Iii SR) Laser System and Accessories | Reliant Technologies, Inc. | 2008 | — |
| −2 | K091115 | ECO2 Laser System | Lutronic Corporation | 2009 | — |
| −1 | K123573 | Youlaser CO2 Laser | Quanta System Spa | 2013 | — |
| 0 (this device) | K182669 | Youlaser CO2 | Quanta System Spa | 2018 | — |
| +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 |
|---|---|---|
| 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 |
|---|---|---|
| 2024 | 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? (1)
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 |
|---|---|---|---|
| * | K123573 | Youlaser CO2 LaserSummary page 4…CFR 878.4810 Product Code: GEX Basis for Submission: Device modifications Primary Predicate Device: Youlaser CO2 (K123573) – Quanta System SpA Performance Standards: There are no mandatory performance standards for this device.… | 2013 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241092 | Youlaser PRIME; Youlaser PRIME CO2; Youlaser PRIME MT | 2024 | 0 |
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 26 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 5 of the 157 ancestors have a recall of any class.
- Of its descendants, K241092 (Quanta System Spa, 2024) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K123573.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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?
When used in traditional, non-fractionated mode 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.
When used in fractionated mode (scanner), it is indicated only for ablative skin resurfacing.
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/K182669 · printed Nov 5, 2026
Cite this page
510(k) Report. “K182669: Youlaser CO2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K182669
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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