510(k) · Cleared
ClearedDeka Smartxide Laser System
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 Sep 5, 2014 as substantially equivalent to K113504 (El.En Electronic Engineering Spa, 2013) and 1 other predicate after a 259-day review. Its family tree reaches back 18 generations to 1995. 10 later devices descend from it.
- Decided
- Sep 5, 2014
- Review
- 259 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 18 generations to K943450 (1995). 354 ancestors in all, the oldest K771218 (1978). 10 later devices descend from it, 3 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 1 generation backK113504 Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa · 2013
- This deviceK133895 Deka Smartxide Laser SystemEl.En S.P.A. · 2014
- Descendant · cites it directly · 7 of its ownK162169 EdgeOne CO2 LaserJeisys Medical, Inc. · 2016
- Descendant · cites it directly · 5 of its ownK201109 CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2020
- Descendant · 2 generations on · 2 of its ownK221597 CO2 Laser SystemSmedtrum Medical Technology Co., Ltd. · 2022
- Descendant · 3 generations on · 1 of its ownK241670 Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser…Beijing Adss Development Co., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK150587 Cortex Laser SystemCynosure, Inc. Dba Ellman · 2015
Show all 18 generations
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 17 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 16 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 15 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 14 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 13 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 12 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 11 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 10 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 9 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 8 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 7 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 6 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 5 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 4 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 3 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 2 generations backK083613 Quanta System Polysurge Diode Laser FamilyQuanta System Spa · 2008
- 1 generation backK113504 Deka Smartxide and Delivery AccessoriesEl.En Electronic Engineering Spa · 2013
- This deviceK133895 Deka Smartxide Laser SystemEl.En S.P.A. · 2014
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 10 · See all- K162169EdgeOne CO2 LaserJeisys Medical, Inc. · 2016 · cites it directly7descendants
- K201109CO2 Laser Therapy SystemShanghai Apolo Medical Technology Co., Ltd. · 2020 · cites it directly5descendants
- K221597CO2 Laser SystemSmedtrum Medical Technology Co., Ltd. · 2022 · 2 generations on2descendants
- K241670Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy System…Beijing Adss Development Co., Ltd. · 2024 · 3 generations on1descendant
- K150587Cortex Laser SystemCynosure, Inc. Dba Ellman · 2015 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −18 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −17 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −16 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −15 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −14 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −13 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −12 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −11 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −10 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −9 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −8 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −7 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −6 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −5 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −4 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −3 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −2 | K083613 | Quanta System Polysurge Diode Laser Family | Quanta System Spa | 2008 | — |
| −1 | K113504 | Deka Smartxide and Delivery Accessories | El.En Electronic Engineering Spa | 2013 | — |
| 0 (this device) | K133895 | Deka Smartxide Laser System | El.En S.P.A. | 2014 | — |
| +1 | K162169 | EdgeOne CO2 Laser | Jeisys Medical, Inc. | 2016 | — |
| +1 | K201109 | CO2 Laser Therapy System | Shanghai Apolo Medical Technology Co., Ltd. | 2020 | — |
| +2 | K221597 | CO2 Laser System | Smedtrum Medical Technology Co., Ltd. | 2022 | — |
| +3 | K241670 | Fractional CO2 Laser Therapy System (FG900-S); Fractional CO2 Laser Therapy… | Beijing Adss Development Co., Ltd. | 2024 | — |
| +1 | K150587 | Cortex Laser System | Cynosure, Inc. Dba Ellman | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1978 | 1 | 0 |
| 1980 | 1 | 0 |
| 1981 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 4 | 0 |
| 1991 | 7 | 0 |
| 1992 | 5 | 0 |
| 1993 | 11 | 0 |
| 1994 | 23 | 0 |
| 1995 | 20 | 0 |
| 1996 | 26 | 0 |
| 1997 | 27 | 0 |
| 1998 | 24 | 0 |
| 1999 | 18 | 0 |
| 2000 | 27 | 0 |
| 2001 | 29 | 0 |
| 2002 | 34 | 0 |
| 2003 | 29 | 0 |
| 2004 | 18 | 0 |
| 2005 | 11 | 0 |
| 2006 | 4 | 0 |
| 2007 | 5 | 0 |
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | K113504 | Deka Smartxide and Delivery AccessoriesSummary page 4…ical, Powered, Laser 79-GEX 21 CFR 878.4810 Equivalent Device: DEKA SmartXide2 Laser System (K113504) and Cynosure Affirm CO2 Laser (K081424) Device Description:… | 2013 |
| * | K081424 | Affirm CO2 and Affirm CO2 HPSummary page 4…21 CFR 878.4810 Equivalent Device: DEKA SmartXide2 Laser System (K113504) and Cynosure Affirm CO2 Laser (K081424) Device Description: DEKA SmartXide2 is a laser wi… | 2009 |
What descends from it? (10)
3 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?
- The line of descent spans 19 years and passes through 8 companies; a new generation was cleared every 10 months on median.
- 16 of the 354 ancestors have a recall of any class.
- Of its descendants, K162169 (Jeisys Medical, Inc., 2016) has gone furthest, with 7 descendants of its own.
- 1 other device also cites its predicate K113504.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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?
It is indicated for incision, excision, ablation, vaporization and coagulation of body soft tissues in medical specialties including aesthetic (dermatology and plastic surgery), podiatry, otolaryngology (ENT), gynaecology, neurosurgery, orthopaedics, general and thorasic surgery (including open and endoscopic), 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/K133895 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133895: Deka Smartxide 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/K133895
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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