510(k) · Cleared
ClearedYoulaser CO2 Laser System
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 Aug 25, 2011 as substantially equivalent to K072159 (El.En Electronic Engineering Spa, 2007) after a 79-day review. Its family tree reaches back 1 generation to 2007. 3 later devices descend from it.
- Decided
- Aug 25, 2011
- Review
- 79 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K072159 (2007). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK072159 Smart CO2 (Smartxide, Smart US20D) with Dot ScannerEl.En Electronic Engineering Spa · 2007
- This deviceK111592 Youlaser CO2 Laser SystemQuanta System Spa · 2011
- Descendant · cites it directly · 2 of its ownK133915 Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd. · 2014
- Descendant · 2 generations on · 1 of its ownK150587 Cortex Laser SystemCynosure, Inc. Dba Ellman · 2015
- Descendant · 3 generations on · 0 of its ownK161356 Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd · 2016
Most influential descendants
Showing 3 of 3 · See all- K133915Galaxy CO2 Laser SystemBeijing Toplaser Technology Co., Ltd. · 2014 · cites it directly2descendants
- K150587Cortex Laser SystemCynosure, Inc. Dba Ellman · 2015 · 2 generations on1descendant
- K161356Matrix LS-40 CO2 Laser SystemShanghai Wonderful Opto-Electrics Tech.Co.,Ltd · 2016 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K072159 | Smart CO2 (Smartxide, Smart US20D) with Dot Scanner | El.En Electronic Engineering Spa | 2007 | — |
| 0 (this device) | K111592 | Youlaser CO2 Laser System | Quanta System Spa | 2011 | — |
| +1 | K133915 | Galaxy CO2 Laser System | Beijing Toplaser Technology Co., Ltd. | 2014 | — |
| +2 | K150587 | Cortex Laser System | Cynosure, Inc. Dba Ellman | 2015 | — |
| +3 | K161356 | Matrix LS-40 CO2 Laser System | Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K072159 | Smart CO2 (Smartxide, Smart US20D) with Dot ScannerSummary page 1…cation Name: Instrument, surgical, powered, laser Predicate Devices: - El.En S.p.A Smart C02 Laser System (K072159); Intended Use /YOULASER C02 Laser is indicated for incision, Indications for Use: excision, ablation, vaporiza… | 2007 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K133915 | Galaxy CO2 Laser System | 2014 | 2 |
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?
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, 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 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), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery. YOULASER C02 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application: Dyschromia…
Read the full statement (106 words)
YOULASER C02 Laser 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), otolaryngology (ENT), gynaecology, neurosurgery, dental and oral surgery and genitourinary surgery.
YOULASER C02 Laser with the scanning unit is indicated for full ablative skin resurfacing for the following application:
Dyschromia,
Atrophic + Acne scars,
Hypertrophic scars
The scanning modality is intended for the above described use. In this case the handpiece simply enables a laser-tissue interaction in different positions within a specific area.
The safety and effectiveness of this scanner/device has not been evaluated as a fractionated scanner/device
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K111592 · printed Nov 6, 2026
Cite this page
510(k) Report. “K111592: Youlaser CO2 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/K111592
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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