510(k) · Cleared
ClearedVenus Versa System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Venus Concept, Ltd. · ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
Cleared on Mar 21, 2016 as substantially equivalent to K060516 (Danish Dermatologic Development A/S, 2006) and 4 other predicates after an 88-day review. Its family tree reaches back 18 generations to 1995. 1 later device descends from it.
- Decided
- Mar 21, 2016
- Review
- 88 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 18 generations to K943450 (1995). 274 ancestors in all, the oldest K800617 (1980). 1 later device descends from it, 1 citing it directly.
- Root · 18 generations backK943450 Arthrocare Arthroscopic Electrosurgery System Model 970Arthrocare Corp. · 1995
- 14 generations between
- 3 generations backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- 2 generations backK111670 Venus Freeze (MP)2 SystemVenus Concept, Ltd. · 2012
- 1 generation backK142910 Legacy BXVenus Concept USA, Inc. · 2014
- This deviceK153717 Venus Versa SystemVenus Concept, Ltd. · 2016
- Descendant · cites it directly · 0 of its ownK232192 Venus Versa PRO SystemVenus Concept, Inc. · 2023
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 backK051214 Aluma Skin Renewal SystemLumenis, Inc. · 2005
- 5 generations backK070004 AccentAlma Lasers, Ltd. · 2007
- 4 generations backK083461 Imagine TC Skin Therapy SystemEndymion Medical, Ltd. · 2009
- 3 generations backK100586 Venus Freeze SystemVenus Concept, Ltd. · 2010
- 2 generations backK111670 Venus Freeze (MP)2 SystemVenus Concept, Ltd. · 2012
- 1 generation backK142910 Legacy BXVenus Concept USA, Inc. · 2014
- This deviceK153717 Venus Versa SystemVenus Concept, Ltd. · 2016
Most influential descendants
Showing 1 of 1 · See all- K232192Venus Versa PRO SystemVenus Concept, Inc. · 2023 · cites it directly0descendants
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 | K051214 | Aluma Skin Renewal System | Lumenis, Inc. | 2005 | — |
| −5 | K070004 | Accent | Alma Lasers, Ltd. | 2007 | — |
| −4 | K083461 | Imagine TC Skin Therapy System | Endymion Medical, Ltd. | 2009 | — |
| −3 | K100586 | Venus Freeze System | Venus Concept, Ltd. | 2010 | — |
| −2 | K111670 | Venus Freeze (MP)2 System | Venus Concept, Ltd. | 2012 | — |
| −1 | K142910 | Legacy BX | Venus Concept USA, Inc. | 2014 | — |
| 0 (this device) | K153717 | Venus Versa System | Venus Concept, Ltd. | 2016 | — |
| +1 | K232192 | Venus Versa PRO System | Venus Concept, Inc. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1980 | 1 | 0 |
| 1982 | 2 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 0 |
| 1988 | 2 | 0 |
| 1989 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 5 | 0 |
| 1992 | 3 | 0 |
| 1993 | 8 | 0 |
| 1994 | 15 | 0 |
| 1995 | 14 | 0 |
| 1996 | 20 | 0 |
| 1997 | 22 | 0 |
| 1998 | 14 | 0 |
| 1999 | 11 | 0 |
| 2000 | 21 | 0 |
| 2001 | 24 | 0 |
| 2002 | 28 | 0 |
| 2003 | 24 | 0 |
| 2004 | 12 | 0 |
| 2005 | 8 | 0 |
| 2006 | 4 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 0 |
| 2010 | 1 | 0 |
| 2011 | 2 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 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? (5)
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 |
|---|---|---|---|
| * | K060516 | Ellipse 12PL, Model 9ESL7228Summary page 4…878.4810), Product Codes: ONF, GEX Predicate/Reference Devices Predicate Devices: Danish Dermatologic Development A/S’s Ellipse I2PL System (K060516) MATTIOLI Pulse TWO/THREE Plus Family (K100053) Global Medical Technology S.L.’s Platinum GMT IPL Sys… | 2006 |
| * | K100053 | Mattioli Pulse Two/Three Plus FamilySummary page 4…Devices Predicate Devices: Danish Dermatologic Development A/S’s Ellipse I2PL System (K060516) MATTIOLI Pulse TWO/THREE Plus Family (K100053) Global Medical Technology S.L.’s Platinum GMT IPL System Cloud (K140668) Venus Concept Ltd.’s Venus… | 2010 |
| * | K140668 | Platinumgmt Ipl System CloudSummary page 4…Ellipse I2PL System (K060516) MATTIOLI Pulse TWO/THREE Plus Family (K100053) Global Medical Technology S.L.’s Platinum GMT IPL System Cloud (K140668) Venus Concept Ltd.’s Venus Legacy BX Device (K142910) Venus Concept Ltd.’s Viva SR Device (K150161)… | 2014 |
| * | K142910 | Legacy BXSummary page 4…E Plus Family (K100053) Global Medical Technology S.L.’s Platinum GMT IPL System Cloud (K140668) Venus Concept Ltd.’s Venus Legacy BX Device (K142910) Venus Concept Ltd.’s Viva SR Device (K150161) Reference Devices: Lumenis M22 System (K142860)… | 2014 |
| * | K150161 | Venus Viva SR DeviceSummary page 4…ogy S.L.’s Platinum GMT IPL System Cloud (K140668) Venus Concept Ltd.’s Venus Legacy BX Device (K142910) Venus Concept Ltd.’s Viva SR Device (K150161) Reference Devices: Lumenis M22 System (K142860); Alma Laser’s Harmony Lite Multi-Application… | 2015 |
| † | K142860 | Lumenis M22 System | 2015 |
| † | K141237 | Harmony Lite | 2015 |
| † | K072564 | Alma Lasers Harmony XL Multi-Application Platform | 2008 |
| † | K123257 | Emvera Diolux | 2012 |
| † | K053628 | Lightsheer Duet Laser System | 2006 |
| † | K150051 | Exilite | 2015 |
| † | K122995 | Intense Pulsed Light (Ipl) Systems | 2013 |
| † | K041086 | Palomar Starlux Pulsed Light System | 2005 |
| † | K113018 | Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based Platform | 2012 |
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 |
|---|---|---|---|
| K232192 | Venus Versa PRO System | 2023 | 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 21 years and passes through 8 companies; a new generation was cleared every 1.2 years on median.
- 10 of the 274 ancestors have a recall of any class.
- Of its descendants, K232192 (Venus Concept, Inc., 2023) has gone furthest, with 0 descendants of its own.
- 4 other devices also cite its predicate K060516.
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. 2016, 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 Venus Versa System is a multi-application device intended to be used in aesthetic and cosmetic procedures. The SR515 and SR580 IPL applicators are indicated for the following: • Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules. • Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and…
Read the full statement (204 words)
The Venus Versa System is a multi-application device intended to be used in aesthetic and cosmetic procedures.
The SR515 and SR580 IPL applicators are indicated for the following:
• Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules.
• Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas and spider angiomas, poikiloderma of civatte, leg veins and venous malformations.
The HR650, HR690, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. 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 regimen.
The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris.
The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for females for the non-invasive treatment of moderate to severe facial wrinkles and rhytides in Fitzpatrick skin types I-IV.
The Viva applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153717 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153717: Venus Versa System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153717
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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