510(k) · Cleared
ClearedSmartxide Tetra Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
El.En S.P.A. · GEX Powered Laser Surgical Instrument
Cleared on Mar 12, 2024 as substantially equivalent to K180193 (El.En Electronic Engineering Spa, 2018) after a 21-day review. Its family tree reaches back 3 generations to 2009.
- Decided
- Mar 12, 2024
- Review
- 21 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K081424 (2009). No later device cites it as a predicate yet.
- Root · 3 generations backK081424 Affirm CO2 and Affirm CO2 HPCynosure, Inc. · 2009
- 2 generations backK172362 Deka Smartxide TouchEl.En Electronic Engineering Spa · 2017
- 1 generation backK180193 DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)El.En Electronic Engineering Spa · 2018
- This deviceK240497 Smartxide Tetra ProEl.En S.P.A. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K081424 | Affirm CO2 and Affirm CO2 HP | Cynosure, Inc. | 2009 | — |
| −2 | K172362 | Deka Smartxide Touch | El.En Electronic Engineering Spa | 2017 | — |
| −1 | K180193 | DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) | El.En Electronic Engineering Spa | 2018 | — |
| 0 (this device) | K240497 | Smartxide Tetra Pro | El.En S.P.A. | 2024 | — |
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 |
|---|---|---|---|
| * | K180193 | DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)Summary page 5…se in General and Plastic and in Dermatology Regulatory Class: Class II Product Code: GEX Predicate Device: DEKA Smartxide family (Smartxide Touch, Smartxide Punto) (K180193) Device Description: The SMARTXIDE TETRA PRO DEVICE consists of a 10,600nm carbon dioxide laser (CO2) laser with 40W of maximum… | 2018 |
What descends from it?
No later submission names this one as a predicate yet.
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 15 years and passes through 3 companies; a new generation was cleared every 6.1 years on median.
- None of the 3 ancestors has a recall.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
Incision, excision, ablation, vaporization, and coagulation of body soft tissue including intraoral tissue, in medical specialities 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240497 · printed Nov 4, 2026
Cite this page
510(k) Report. “K240497: Smartxide Tetra Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K240497
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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