510(k) · Cleared
ClearedDEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)
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 Feb 21, 2018 as substantially equivalent to K172362 (El.En Electronic Engineering Spa, 2017) after a 28-day review. Its family tree reaches back 2 generations to 2009. 1 later device descends from it.
- Decided
- Feb 21, 2018
- Review
- 28 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K081424 (2009). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK081424 Affirm CO2 and Affirm CO2 HPCynosure, Inc. · 2009
- 1 generation backK172362 Deka Smartxide TouchEl.En Electronic Engineering Spa · 2017
- This deviceK180193 DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto)El.En Electronic Engineering Spa · 2018
- Descendant · cites it directly · 0 of its ownK240497 Smartxide Tetra ProEl.En S.P.A. · 2024
Most influential descendants
Showing 1 of 1 · See all- K240497Smartxide Tetra ProEl.En S.P.A. · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K081424 | Affirm CO2 and Affirm CO2 HP | Cynosure, Inc. | 2009 | — |
| −1 | K172362 | Deka Smartxide Touch | El.En Electronic Engineering Spa | 2017 | — |
| 0 (this device) | K180193 | DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto) | El.En Electronic Engineering Spa | 2018 | — |
| +1 | K240497 | Smartxide Tetra Pro | El.En S.P.A. | 2024 | — |
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 |
|---|---|---|---|
| * | K172362 | Deka Smartxide TouchSummary page 4…er Surgical Instrument for use in General and Plastic Surgery and in Dermatology (GEX) Classification Number: 21 CFR 878.4810 Equivalent Devices: DEKA Smartxide Touch (K172362) Device Description: The DEKA Smartxide Family of laser system are medical devices equipped with a 10.600 nm Carbon Dioxide (CO2… | 2017 |
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 |
|---|---|---|---|
| K240497 | Smartxide Tetra Pro | 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 9 years and passes through 2 companies; a new generation was cleared every 8.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K240497 (El.En S.P.A., 2024) has gone furthest, with 0 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. 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?
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 as stated in the FDA summary.
https://510kreport.com/device/K180193 · printed Nov 5, 2026
Cite this page
510(k) Report. “K180193: DEKA SMARTXIDE Family (Smartxide Touch, Smartxide Punto).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K180193
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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