510(k) · Cleared
ClearedSmartxide
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cynosure, Inc. · GEX Powered Laser Surgical Instrument
Cleared on May 9, 2003 after a 22-day review. The FDA summary names its predicate without a number. 33 later devices descend from it.
- Decided
- May 9, 2003
- Review
- 22 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 0
33 later devices descend from it, 3 citing it directly.
- This deviceK031224 SmartxideCynosure, Inc. · 2003
- Descendant · cites it directly · 30 of its ownK080496 Mosaic ECO2 Laser SystemLutronic Corporation · 2008
- Descendant · cites it directly · 27 of its ownK091115 ECO2 Laser SystemLutronic Corporation · 2009
- Descendant · 2 generations on · 19 of its ownK123573 Youlaser CO2 LaserQuanta System Spa · 2013
- Descendant · 3 generations on · 14 of its ownK160312 Fraxis DuoIlooda Co,., Ltd. · 2016
- Descendant · 4 generations on · 10 of its ownK170325 Secret RFIlooda Co,., Ltd. · 2017
Showing 5 of 33 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 33 · See all- K080496Mosaic ECO2 Laser SystemLutronic Corporation · 2008 · cites it directly30descendants
- K091115ECO2 Laser SystemLutronic Corporation · 2009 · cites it directly27descendants
- K123573Youlaser CO2 LaserQuanta System Spa · 2013 · 2 generations on19descendants
- K160312Fraxis DuoIlooda Co,., Ltd. · 2016 · 3 generations on14descendants
- K170325Secret RFIlooda Co,., Ltd. · 2017 · 4 generations on10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K031224 | Smartxide | Cynosure, Inc. | 2003 | — |
| +1 | K080496 | Mosaic ECO2 Laser System | Lutronic Corporation | 2008 | — |
| +1 | K091115 | ECO2 Laser System | Lutronic Corporation | 2009 | — |
| +2 | K123573 | Youlaser CO2 Laser | Quanta System Spa | 2013 | — |
| +3 | K160312 | Fraxis Duo | Ilooda Co,., Ltd. | 2016 | — |
| +4 | K170325 | Secret RF | Ilooda Co,., Ltd. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2019 | 1 | 0 |
| 2022 | 2 | 0 |
| 2023 | 1 | 0 |
| 2024 | 6 | 0 |
| 2025 | 3 | 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 |
|---|---|---|---|
| * | — | PhotoAppeal laser Named without a submission number |
What descends from it? (33)
See all 333 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, K080496 (Lutronic Corporation, 2008) has gone furthest, with 30 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.
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 CO, surgical lasers are indicated for incision, excision, and coagulation of body soft tissuc. It's typical applications include dermatology, plastic surgery, urology, gastroenterology, neurosurgery, gynecology and gcneral surgery.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031224 · printed Nov 6, 2026
Cite this page
510(k) Report. “K031224: Smartxide.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K031224
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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