510(k) · Cleared
ClearedDeka Luxea
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 16, 2019 as substantially equivalent to K152714 (Quanta System Spa, 2015) and 5 other predicates after a 91-day review. Its family tree reaches back 22 generations to 1995. 4 later devices descend from it.
- Decided
- Dec 16, 2019
- Review
- 91 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 6
Its longest line of descent runs back 22 generations to K943450 (1995). 549 ancestors in all, the oldest K771218 (1978). 4 later devices descend from it, 4 citing it directly.
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 18 generations between
- 3 generations backK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- 2 generations backK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
- 1 generation backK152714 Quanta ForteQuanta System Spa · 2015
- This deviceK192539 Deka LuxeaEl.En Electronic Engineering Spa · 2019
- Descendant · cites it directly · 0 of its ownK234057 NirvanaEl.En S.P.A. · 2024
- Descendant · cites it directly · 0 of its ownK220794 10PLTentech Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK212790 XLase PlusBiotec Italia, Srl · 2022
- Descendant · cites it directly · 0 of its ownK200616 E>EyeCE-Swin · 2020
Show all 22 generations
- Root · 22 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 21 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 20 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 19 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 18 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 17 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 16 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 15 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 14 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 13 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 12 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 11 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 10 generations backK041959 Polaris DS/CometSyneron Medical, Ltd. · 2004
- 9 generations backK053540 Intermedic Diode Laser Family 810NM and 980NM (and the Delivery…Intermedic Arfran, SA · 2006
- 8 generations backK071295 100W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 7 generations backK072106 150W Ceralas D 980NM Diode LaserBiolitec, Inc. · 2007
- 6 generations backK083682 180W Cerelas D 980NM Diode Laser, Model D180Biolitec, Inc. · 2009
- 5 generations backK082230 Vectra Plus Laser System and AccessoriesXintec Corporation · 2010
- 4 generations backK101916 Joule Multi-Platform SystemSciton, Inc · 2011
- 3 generations backK140009 Soprano Ice Multi-Application & Multi-Technology PlatformAlma Lasers, Ltd. · 2014
- 2 generations backK143519 The MeDioStar NeXT FamilyAsclepion Laser Technologies GmbH · 2015
- 1 generation backK152714 Quanta ForteQuanta System Spa · 2015
- This deviceK192539 Deka LuxeaEl.En Electronic Engineering Spa · 2019
Most influential descendants
Showing 4 of 4 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −22 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −21 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −20 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −19 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −18 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −17 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −16 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −15 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −14 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −13 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −12 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −11 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −10 | K041959 | Polaris DS/Comet | Syneron Medical, Ltd. | 2004 | — |
| −9 | K053540 | Intermedic Diode Laser Family 810NM and 980NM (and the Delivery Accessories… | Intermedic Arfran, SA | 2006 | — |
| −8 | K071295 | 100W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −7 | K072106 | 150W Ceralas D 980NM Diode Laser | Biolitec, Inc. | 2007 | — |
| −6 | K083682 | 180W Cerelas D 980NM Diode Laser, Model D180 | Biolitec, Inc. | 2009 | — |
| −5 | K082230 | Vectra Plus Laser System and Accessories | Xintec Corporation | 2010 | — |
| −4 | K101916 | Joule Multi-Platform System | Sciton, Inc | 2011 | — |
| −3 | K140009 | Soprano Ice Multi-Application & Multi-Technology Platform | Alma Lasers, Ltd. | 2014 | — |
| −2 | K143519 | The MeDioStar NeXT Family | Asclepion Laser Technologies GmbH | 2015 | — |
| −1 | K152714 | Quanta Forte | Quanta System Spa | 2015 | — |
| 0 (this device) | K192539 | Deka Luxea | El.En Electronic Engineering Spa | 2019 | — |
| +1 | K234057 | Nirvana | El.En S.P.A. | 2024 | — |
| +1 | K220794 | 10PL | Tentech Co., Ltd. | 2022 | — |
| +1 | K212790 | XLase Plus | Biotec Italia, Srl | 2022 | — |
| +1 | K200616 | E>EyeC | E-Swin | 2020 | — |
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 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 4 | 0 |
| 1990 | 7 | 0 |
| 1991 | 10 | 0 |
| 1992 | 5 | 0 |
| 1993 | 12 | 0 |
| 1994 | 25 | 0 |
| 1995 | 27 | 0 |
| 1996 | 30 | 0 |
| 1997 | 31 | 0 |
| 1998 | 31 | 0 |
| 1999 | 27 | 0 |
| 2000 | 35 | 0 |
| 2001 | 34 | 0 |
| 2002 | 42 | 0 |
| 2003 | 48 | 0 |
| 2004 | 35 | 0 |
| 2005 | 30 | 0 |
| 2006 | 17 | 0 |
| 2007 | 18 | 0 |
| 2008 | 19 | 0 |
| 2009 | 11 | 0 |
| 2010 | 3 | 0 |
| 2011 | 7 | 0 |
| 2013 | 2 | 0 |
| 2015 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 2 | 0 |
| 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? (6)
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 |
|---|---|---|---|
| * | K152714 | Quanta ForteSummary page 5…urgical Instrument for use in General and Plastic Surgery and in Dermatology Product Code : GEX, ONF Classification Number: 21 CFR 878.4810 Equivalent Devices: K152714 – Quanta Forte K103288 – DEKA Synchro FT K142860 – Lumenis M22 K150516 – DEKA Synchro Replay K072564… | 2015 |
| * | K103288 | Deka Synchro FTSummary page 5…General and Plastic Surgery and in Dermatology Product Code : GEX, ONF Classification Number: 21 CFR 878.4810 Equivalent Devices: K152714 – Quanta Forte K103288 – DEKA Synchro FT K142860 – Lumenis M22 K150516 – DEKA Synchro Replay K072564 – Alma Laser Harmony XLTm Mult… | 2011 |
| * | K142860 | Lumenis M22 SystemSummary page 5…n Dermatology Product Code : GEX, ONF Classification Number: 21 CFR 878.4810 Equivalent Devices: K152714 – Quanta Forte K103288 – DEKA Synchro FT K142860 – Lumenis M22 K150516 – DEKA Synchro Replay K072564 – Alma Laser Harmony XLTm Multi-Application Platform K02… | 2015 |
| * | K150516 | Deka Synchro Repla:Y Family of Laser SystemsSummary page 5…GEX, ONF Classification Number: 21 CFR 878.4810 Equivalent Devices: K152714 – Quanta Forte K103288 – DEKA Synchro FT K142860 – Lumenis M22 K150516 – DEKA Synchro Replay K072564 – Alma Laser Harmony XLTm Multi-Application Platform K020941 – Palomar LuxG… | 2015 |
| * | K072564 | Alma Lasers Harmony XL Multi-Application PlatformSummary page 5…CFR 878.4810 Equivalent Devices: K152714 – Quanta Forte K103288 – DEKA Synchro FT K142860 – Lumenis M22 K150516 – DEKA Synchro Replay K072564 – Alma Laser Harmony XLTm Multi-Application Platform K020941 – Palomar LuxG… | 2008 |
| * | K020941 | Palomar Luxg HandpieceSummary page 5…K103288 – DEKA Synchro FT K142860 – Lumenis M22 K150516 – DEKA Synchro Replay K072564 – Alma Laser Harmony XLTm Multi-Application Platform K020941 – Palomar LuxG 1 Device Description: The DEKA LUXEA is a vers… | 2002 |
What descends from it? (4)
4 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 24 years and passes through 11 companies; a new generation was cleared every 10 months on median.
- 28 of the 549 ancestors have a recall of any class.
- Of its descendants, K234057 (El.En S.P.A., 2024) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K152714.
How does its category compare?
All GEX devicesGEX Powered Laser Surgical Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
VIVID LASER handpiece: Indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction. Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime SPARKS LASER handpiece : Indicated for removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types…
Read the full statement (333 words)
VIVID LASER handpiece:
Indicated for the treatment of benign vascular lesions, benign pigmented lesions, hair removal and permanent hair reduction.
Permanent hair reduction is defined as the long-term, stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regime
SPARKS LASER handpiece :
Indicated for removal of unwanted hair, for stable long term or permanent hair reduction (Skin Types Fitzpatrick I-VI), photocoagulation and hemostasis of benign pigmented and vascular lesions, such as but not limited to warts, teleangiectasia, leg veins and spider veins, treatment of benign pigmented lesions.
PRISMA LASER handpiece:
Indicated for removal of dark tattoos and treatment of benign pigmented lesions.
RUBER, LILAC Pulsed Light handpieces:
Permanent hair reduction. photocoagulation of benign vascular lesions, photothermolysis of blood vessels, treatment of benign pigmented lesions.
Different wavelength ranges of Pulsed Light attachment are indicated for the various treatments and skin types. as indicated in the following table:
Pulsed light Hair reduction Benign Blood vessels Benign
Wavelength range Vascular lesions Pigmented lesions
500-1200nm - Skin Types I, II Skin Types I, II -
520-1200nm - SkinType III Skin Type III Skin Types I, II
550-1200nm Skin Types I, II - - Skin Type III
600-1200nm Skin Type III - - -
650-1200nm Skin Type IV - - Skin Type IV
LAZUR Pulsed Light handpiece:
The handpiece (with and without contact-cooling) is indicated for:
-The treatment of moderate inflammatory acne vulgaris.
-The treatment of benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles).
-The treatment of benign cutaneous lesions including warts, scars and striae.
-The treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea,
angiomas and spider angiomas, poikiloderma of Civatte, leg veins and venous malformations.
- Use on all skin types (Fitzpatrick I-VI).
VIRIDIS Pulsed Light handpiece:
Photocoagulation of benign dermatological vascular lesions, photothermolysis of blood vessels (treatment of facial and-leg veins), and the treatment of benign pigmented lesions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K192539 · printed Nov 3, 2026
Cite this page
510(k) Report. “K192539: Deka Luxea.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K192539
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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