510(k) · Cleared
ClearedDeka Toro
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 May 16, 2024 as substantially equivalent to K202503 (Quanta System Spa, 2020) and 2 other predicates after a 58-day review. Its family tree reaches back 28 generations to 1995.
- Decided
- May 16, 2024
- Review
- 58 days
- Class
- Class II
- Product code
- GEX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 28 generations to K943450 (1995). 318 ancestors in all, the oldest K800617 (1980). No later device cites it as a predicate yet.
- Root · 28 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 24 generations between
- 3 generations backK191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa · 2019
- 2 generations backK202503 ChromeQuanta System Spa · 2020
- 1 generation backK213569 HOLLYWOOD SPECTRA Laser SystemLutronic Corporation · 2022
- This deviceK240752 Deka ToroEl.En S.P.A. · 2024
Show all 28 generations
- Root · 28 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 27 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 26 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 25 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 24 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 23 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 22 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 21 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 20 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 19 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 18 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 17 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 16 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 15 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 14 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 13 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 12 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 11 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 10 generations backK142372 Pico Way Laser SystemCandela Corpation · 2014
- 9 generations backK150326 PicoWay Laser SystemCandela Corporation · 2015
- 8 generations backK152012 EVO platformQuanta System Spa · 2015
- 7 generations backK160368 EVO platformQuanta System Spa · 2016
- 6 generations backK163222 Discovery Pico FamilyQuanta System Spa · 2016
- 5 generations backK171945 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 4 generations backK172376 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 3 generations backK191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa · 2019
- 2 generations backK202503 ChromeQuanta System Spa · 2020
- 1 generation backK213569 HOLLYWOOD SPECTRA Laser SystemLutronic Corporation · 2022
- This deviceK240752 Deka ToroEl.En S.P.A. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −28 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −27 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −26 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −25 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −24 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −23 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −22 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −21 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −20 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −19 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −18 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −17 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −16 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −15 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −14 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −13 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −12 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −11 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −10 | K142372 | Pico Way Laser System | Candela Corpation | 2014 | — |
| −9 | K150326 | PicoWay Laser System | Candela Corporation | 2015 | — |
| −8 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
| −7 | K160368 | EVO platform | Quanta System Spa | 2016 | — |
| −6 | K163222 | Discovery Pico Family | Quanta System Spa | 2016 | — |
| −5 | K171945 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
| −4 | K172376 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
| −3 | K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm | Quanta System Spa | 2019 | — |
| −2 | K202503 | Chrome | Quanta System Spa | 2020 | — |
| −1 | K213569 | HOLLYWOOD SPECTRA Laser System | Lutronic Corporation | 2022 | — |
| 0 (this device) | K240752 | Deka Toro | El.En S.P.A. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 2 | 0 |
| 1990 | 3 | 0 |
| 1991 | 4 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 12 | 0 |
| 1995 | 12 | 0 |
| 1996 | 17 | 0 |
| 1997 | 24 | 0 |
| 1998 | 15 | 0 |
| 1999 | 11 | 0 |
| 2000 | 26 | 0 |
| 2001 | 26 | 0 |
| 2002 | 35 | 0 |
| 2003 | 24 | 0 |
| 2004 | 17 | 0 |
| 2005 | 10 | 0 |
| 2006 | 7 | 0 |
| 2007 | 2 | 0 |
| 2008 | 4 | 0 |
| 2009 | 3 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2013 | 1 | 0 |
| 2014 | 5 | 0 |
| 2015 | 2 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 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? (3)
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 |
|---|---|---|---|
| * | K202503 | ChromeSummary page 6…eral And Plastic Surgery And In Dermatology Product Code: GEX Regulatory Class: Class II Regulation Number: 21 CFR 878.4810 Predicate Devices: QUANTA SYSTYEM CHROME (K202503) LUTRONIC HOLLYWOOD SPECTRA (K213569) LASEROPTEK HELIOS 785 Pico (K230373) 1… | 2020 |
| * | K213569 | HOLLYWOOD SPECTRA Laser SystemSummary page 6…ology Product Code: GEX Regulatory Class: Class II Regulation Number: 21 CFR 878.4810 Predicate Devices: QUANTA SYSTYEM CHROME (K202503) LUTRONIC HOLLYWOOD SPECTRA (K213569) LASEROPTEK HELIOS 785 Pico (K230373) 1 Device Description: T… | 2022 |
| * | K230373 | HELIOS 785 PicoSummary page 6…ass: Class II Regulation Number: 21 CFR 878.4810 Predicate Devices: QUANTA SYSTYEM CHROME (K202503) LUTRONIC HOLLYWOOD SPECTRA (K213569) LASEROPTEK HELIOS 785 Pico (K230373) 1 Device Description: TORO device is a DEKA laser system with… | 2023 |
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 29 years and passes through 14 companies; a new generation was cleared every 10 months on median.
- 15 of the 318 ancestors have a recall of any class.
- 7 other devices also cite its predicate K202503.
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?
785 nm laser source Intended for removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue. 1064 & 532 nm laser sources in Q-Switched, nanosecond mode Intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to: 532 nm (Q-Switched, nanosecond…
Read the full statement (263 words)
785 nm laser source
Intended for removal of tattoos for Fitzpatrick skin types II-IV to treat the following tattoo colors: green and blue.
1064 & 532 nm laser sources in Q-Switched, nanosecond mode
Intended for treatment of benign vascular lesions, benign pigmented lesions, and for hair, tattoo removal and the incision, excision, ablation, vaporization of soft tissue for General dermatology such as, but not limited to:
532 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
• Removal of light ink (red, sky blue, green, tan, purple, and orange) tattoos
• Treatment of benign vascular lesions including, but not limited to:
– port wine birthmarks
– telangiectasias
– spider angioma
– Cherry angioma
– Spider nevi
• Treatment of benign pigmented lesions including, but not limited to:
– cafe-au-Iait birthmarks
– Ephalides, solar lentigines
– senile lentigines
– Becker’s nevi
– freckles
– common nevi
– nevus spilus
– Ota Nevus
• Treatment of seborrheic keratosis
• Treatment of post inflammatory hyperpigmentation
• Skin resurfacing procedures for the treatment of acne scars and wrinkles.
1064 nm (Q-Switched, nanosecond mode), including microbeam handpieces:
• Removal of dark ink (black, blue and brown) tattoos
• Removal of benign pigmented lesions including;
– nevus of Ota
– Café au lait spot
– Ephalides, solar lentigo (lentigines)
– Becker Nevus
– Nevus spilus
• Treatment of common nevi
• Removal or lightening of unwanted hair
• Skin resurfacing procedures for the treatment of acne scars and wrinkles
1064nm laser source in thermal mode (long-pulse) Intended for:
• Treatment of wrinkles
• Treatment of mild to moderate inflammatory acne vulgaris
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240752 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240752: Deka Toro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240752
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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