510(k) · Cleared
ClearedSmart CO2 (Smartxide, Smart US20D) with Dot Scanner
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
El.En Electronic Engineering Spa · GEX Powered Laser Surgical Instrument
Cleared on Dec 27, 2007 after a 143-day review. The FDA summary names its predicate without a number. 32 later devices descend from it.
- Decided
- Dec 27, 2007
- Review
- 143 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
32 later devices descend from it, 6 citing it directly.
- This deviceK072159 Smart CO2 (Smartxide, Smart US20D) with Dot ScannerEl.En Electronic Engineering Spa · 2007
- Descendant · cites it directly · 19 of its ownK123573 Youlaser CO2 LaserQuanta System Spa · 2013
- Descendant · 2 generations on · 14 of its ownK160312 Fraxis DuoIlooda Co,., Ltd. · 2016
- Descendant · 3 generations on · 10 of its ownK170325 Secret RFIlooda Co,., Ltd. · 2017
- Descendant · cites it directly · 4 of its ownK123037 LightscalpelLightscalpel, LLC · 2012
- Descendant · 4 generations on · 3 of its ownK210084 SilkroHironic Co., Ltd. · 2022
Showing 5 of 32 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 32 · See all- K123573Youlaser CO2 LaserQuanta System Spa · 2013 · cites it directly19descendants
- K160312Fraxis DuoIlooda Co,., Ltd. · 2016 · 2 generations on14descendants
- K170325Secret RFIlooda Co,., Ltd. · 2017 · 3 generations on10descendants
- K123037LightscalpelLightscalpel, LLC · 2012 · cites it directly4descendants
- K210084SilkroHironic Co., Ltd. · 2022 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072159 | Smart CO2 (Smartxide, Smart US20D) with Dot Scanner | El.En Electronic Engineering Spa | 2007 | — |
| +1 | K123573 | Youlaser CO2 Laser | Quanta System Spa | 2013 | — |
| +2 | K160312 | Fraxis Duo | Ilooda Co,., Ltd. | 2016 | — |
| +3 | K170325 | Secret RF | Ilooda Co,., Ltd. | 2017 | — |
| +1 | K123037 | Lightscalpel | Lightscalpel, LLC | 2012 | — |
| +4 | K210084 | Silkro | Hironic Co., Ltd. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 7 | 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? (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 |
|---|---|---|---|
| * | — | Lumenis UltraPulse Encore lasers and delivery device accessories Named without a submission number |
What descends from it? (32)
See all 326 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?
- Of its descendants, K123573 (Quanta System Spa, 2013) has gone furthest, with 19 descendants of its own.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 smart CO2 (SmartXide and Smart US20D) Lasers with DOT scanner are 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.
The use with the scanning unit is indicated for ablative skin resurfacing.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072159 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072159: Smart CO2 (Smartxide, Smart US20D) with Dot Scanner.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072159
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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