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 May 16, 2024 as substantially equivalent to K202503 (Quanta System Spa, 2020) and 2 other predicates after a 204-day review. Its family tree reaches back 27 generations to 1995. 1 later device descends from it.
- Decided
- May 16, 2024
- Review
- 204 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 27 generations to K943450 (1995). 404 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 23 generations between
- 3 generations backK172376 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 2 generations backK191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa · 2019
- 1 generation backK202503 ChromeQuanta System Spa · 2020
- This deviceK233473 Deka LotusEl.En S.P.A. · 2024
- Descendant · cites it directly · 0 of its ownK250281 Deka LotusEl.En S.P.A. · 2025
Show all 27 generations
- Root · 27 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 26 generations backK961069 Arthrocare Urologic Multi-Electrode Electrosurgery SystemArthrocare Corp. · 1996
- 25 generations backK962445 Arthrocare Dental Electrosurgery SystemArthrocare Corp. · 1996
- 24 generations backK964849 Arthrocare Dermatologic Electrosurgery SystemArthrocare Corp. · 1997
- 23 generations backK973478 Arthrocare Sinus Electrosurgery SystemArthrocare Corp. · 1998
- 22 generations backK981870 Visage Cosmetic Surgery SystemArthrocare Corp. · 1998
- 21 generations backK000944 Thermage Thermacool SystemThermage, Inc. · 2000
- 20 generations backK013034 Modification to: Thermacool IiaThermage, Inc. · 2001
- 19 generations backK013639 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 18 generations backK021402 Thermage Thermacool TC SystemThermage, Inc. · 2002
- 17 generations backK030142 Thermacool TC SystemThermage, Inc. · 2003
- 16 generations backK031671 Polaris WRSyneron Medical, Ltd. · 2003
- 15 generations backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 14 generations backK060448 Lumenis One Family of Systems; Lumenis One.Lumenis, Ltd. · 2006
- 13 generations backK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- 12 generations backK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- 11 generations backK103118 Revlite Q-Switched ND: Yag Laser System with Nadpiece AdaptorHoya Photonics, Inc. · 2010 · Recalled
- 10 generations backK121346 Picosure WorkstationCynosure, Inc. · 2012
- 9 generations backK142372 Pico Way Laser SystemCandela Corpation · 2014
- 8 generations backK150326 PicoWay Laser SystemCandela Corporation · 2015
- 7 generations backK152012 EVO platformQuanta System Spa · 2015
- 6 generations backK160368 EVO platformQuanta System Spa · 2016
- 5 generations backK163222 Discovery Pico FamilyQuanta System Spa · 2016
- 4 generations backK171945 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 3 generations backK172376 Discovery Pico, Discovery Pico PlusQuanta System Spa · 2017
- 2 generations backK191842 Discovery Pico, Discovery Pico Plus, Discovery Pico DermQuanta System Spa · 2019
- 1 generation backK202503 ChromeQuanta System Spa · 2020
- This deviceK233473 Deka LotusEl.En S.P.A. · 2024
Most influential descendants
Showing 1 of 1 · See all- K250281Deka LotusEl.En S.P.A. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −27 | K943450 | Arthrocare Arthroscopic Electrosurgery System Model 970 | Arthrocare Corp. | 1995 | — |
| −26 | K961069 | Arthrocare Urologic Multi-Electrode Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −25 | K962445 | Arthrocare Dental Electrosurgery System | Arthrocare Corp. | 1996 | — |
| −24 | K964849 | Arthrocare Dermatologic Electrosurgery System | Arthrocare Corp. | 1997 | — |
| −23 | K973478 | Arthrocare Sinus Electrosurgery System | Arthrocare Corp. | 1998 | — |
| −22 | K981870 | Visage Cosmetic Surgery System | Arthrocare Corp. | 1998 | — |
| −21 | K000944 | Thermage Thermacool System | Thermage, Inc. | 2000 | — |
| −20 | K013034 | Modification to: Thermacool Iia | Thermage, Inc. | 2001 | — |
| −19 | K013639 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −18 | K021402 | Thermage Thermacool TC System | Thermage, Inc. | 2002 | — |
| −17 | K030142 | Thermacool TC System | Thermage, Inc. | 2003 | — |
| −16 | K031671 | Polaris WR | Syneron Medical, Ltd. | 2003 | — |
| −15 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −14 | K060448 | Lumenis One Family of Systems; Lumenis One. | Lumenis, Ltd. | 2006 | — |
| −13 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| −12 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| −11 | K103118 | Revlite Q-Switched ND: Yag Laser System with Nadpiece Adaptor | Hoya Photonics, Inc. | 2010 | 1 |
| −10 | K121346 | Picosure Workstation | Cynosure, Inc. | 2012 | — |
| −9 | K142372 | Pico Way Laser System | Candela Corpation | 2014 | — |
| −8 | K150326 | PicoWay Laser System | Candela Corporation | 2015 | — |
| −7 | K152012 | EVO platform | Quanta System Spa | 2015 | — |
| −6 | K160368 | EVO platform | Quanta System Spa | 2016 | — |
| −5 | K163222 | Discovery Pico Family | Quanta System Spa | 2016 | — |
| −4 | K171945 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
| −3 | K172376 | Discovery Pico, Discovery Pico Plus | Quanta System Spa | 2017 | — |
| −2 | K191842 | Discovery Pico, Discovery Pico Plus, Discovery Pico Derm | Quanta System Spa | 2019 | — |
| −1 | K202503 | Chrome | Quanta System Spa | 2020 | — |
| 0 (this device) | K233473 | Deka Lotus | El.En S.P.A. | 2024 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 K250281 Deka Lotusscore 17.0 · 28 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 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) Palomar Icon (K110907) Pollogen Legend+™ System (K173503) Device Description: The DEKA Lotus is a device provided with two puls… | 2020 |
| * | K110907 | Palomar Icon (TM) Aesthetic SystemSummary page 5…ories. Product Code: ONF, GEI Regulatory Class: Class II Regulation Number: 21 CFR 878.4810 21 CFR. 878.4400 Predicate Devices: Quanta Chrome (K202503) Palomar Icon (K110907) Pollogen Legend+™ System (K173503) Device Description: The DEKA Lotus is a device provided with two pulsed light handpieces and… | 2011 |
| * | K173503 | Pollogen Legend SystemSummary page 5…ulatory Class: Class II Regulation Number: 21 CFR 878.4810 21 CFR. 878.4400 Predicate Devices: Quanta Chrome (K202503) Palomar Icon (K110907) Pollogen Legend+™ System (K173503) Device Description: The DEKA Lotus is a device provided with two pulsed light handpieces and a RF handpiece.… | 2018 |
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 |
|---|---|---|---|
| K250281 | Deka Lotus | 2025 | 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 29 years and passes through 13 companies; a new generation was cleared every 9 months on median.
- 19 of the 404 ancestors have a recall of any class.
- Of its descendants, K250281 (El.En S.P.A., 2025) has gone furthest, with 0 descendants of its own.
- 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. 2024, 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 590nm pulsed light handpiece is indicated for permanent hair removal. 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. * 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 benign…
Read the full statement (113 words)
* The DEKA LOTUS 590nm pulsed light handpiece is indicated for permanent hair removal. 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.
* 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 benign 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K233473 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233473: 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/K233473
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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