510(k) · Cleared
ClearedDeka Lotus
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
El.En S.P.A. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Feb 26, 2025 as substantially equivalent to K202503 (Quanta System Spa, 2020) and 1 other predicate after a 26-day review. Its family tree reaches back 28 generations to 1995.
- Decided
- Feb 26, 2025
- Review
- 26 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 28 generations to K943450 (1995). 405 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 backK233473 Deka LotusEl.En S.P.A. · 2024
- This deviceK250281 Deka LotusEl.En S.P.A. · 2025
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 backK233473 Deka LotusEl.En S.P.A. · 2024
- This deviceK250281 Deka LotusEl.En S.P.A. · 2025
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 | K233473 | Deka Lotus | El.En S.P.A. | 2024 | — |
| 0 (this device) | K250281 | Deka Lotus | El.En S.P.A. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1984 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 2 | 0 |
| 1987 | 2 | 0 |
| 1988 | 4 | 0 |
| 1989 | 3 | 0 |
| 1990 | 4 | 0 |
| 1991 | 7 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 17 | 0 |
| 1995 | 17 | 0 |
| 1996 | 22 | 0 |
| 1997 | 27 | 0 |
| 1998 | 20 | 0 |
| 1999 | 15 | 0 |
| 2000 | 28 | 0 |
| 2001 | 28 | 0 |
| 2002 | 39 | 0 |
| 2003 | 32 | 0 |
| 2004 | 21 | 0 |
| 2005 | 18 | 0 |
| 2006 | 11 | 0 |
| 2007 | 15 | 0 |
| 2008 | 9 | 0 |
| 2009 | 6 | 0 |
| 2010 | 3 | 0 |
| 2011 | 3 | 0 |
| 2012 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 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 ONF? 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 ONF device
- #1 K233473 Deka Lotusscore 18.1 · 27 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 |
|---|---|---|---|
| * | K202503 | ChromeSummary page 5…ation device and accessories. Product Code: ONF, GEI Regulatory Class: Class II Regulation Number: 21 CFR 878.4810 21 CFR. 878.4400 Predicate Devices: Quanta Chrome (K202503) DEKA LOTUS (K233473) Device Description: 1 of 5 The DEKA… | 2020 |
| * | K233473 | Deka LotusSummary page 5…ssories. Product Code: ONF, GEI Regulatory Class: Class II Regulation Number: 21 CFR 878.4810 21 CFR. 878.4400 Predicate Devices: Quanta Chrome (K202503) DEKA LOTUS (K233473) Device Description: 1 of 5 The DEKA LOTUS is a device pr… | 2024 |
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 30 years and passes through 13 companies; a new generation was cleared every 9 months on median.
- 19 of the 405 ancestors have a recall of any class.
- 7 other devices also cite its predicate K202503.
How does its category compare?
All ONF devicesONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · ONF
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONF
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONF
No recall names ONF since 2007.
Adverse event reports per year · ONF
5in 2025
MAUDE reports naming product code ONF, 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 | 0 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 5 | 160 | 0 | 0 |
| 2010 | 4 | 137 | 0 | 0 |
| 2011 | 5 | 166 | 0 | 0 |
| 2012 | 3 | 134 | 0 | 0 |
| 2013 | 10 | 113 | 0 | 0 |
| 2014 | 7 | 118 | 0 | 2 |
| 2015 | 3 | 111 | 0 | 4 |
| 2016 | 5 | 87 | 0 | 6 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 2 | — | 0 | 1 |
| 2019 | 2 | — | 0 | 2 |
| 2020 | 4 | 104 | 0 | 1 |
| 2021 | 4 | 101 | 0 | 2 |
| 2022 | 4 | 165 | 0 | 2 |
| 2023 | 5 | 86 | 0 | 2 |
| 2024 | 5 | 168 | 0 | 3 |
| 2025 | 4 | 192 | 0 | 5 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
• The DEKA LOTUS 570nm pulsed light handpiece is indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions. • The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions…
Read the full statement (103 words)
• The DEKA LOTUS 570nm pulsed light handpiece is indicated for photocoagulation of dermatological benign vascular lesion (i.e. face telangiectasia), photothermolysis of blood vessels (treatment of facial and leg veins), and treatment of benign pigmented lesions.
• The DEKA LOTUS 500G pulsed light handpiece is intended for treatment of benign pigmented lesions, including lentigines, nevi, melasma, and cafe-au-lait; and treatment of vascular lesions, including port wine stains, hemangiomas, angiomas, telangiectasias, rosacea, facial and leg veins.
• The DEKA LOTUS RF handpiece is indicated for use in dermatologic and general surgical procedures for the non-invasive treatment of mild to moderate facial wrinkles and rhytides.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250281 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250281: Deka Lotus.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250281
Report an extraction error
Are you the manufacturer?
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