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 Jan 20, 2016 as substantially equivalent to K060516 (Danish Dermatologic Development A/S, 2006) and 1 other predicate after a 117-day review. Its family tree reaches back 10 generations to 1992.
- Decided
- Jan 20, 2016
- Review
- 117 days
- Class
- Class II
- Product code
- ONF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to K910422 (1992). 63 ancestors in all, the oldest K892514 (1990). No later device cites it as a predicate yet.
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 6 generations between
- 3 generations backK043255 Ellipse Light SPTDanish Dermatologic Development A/S · 2005
- 2 generations backK052688 Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S · 2005
- 1 generation backK060516 Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S · 2006
- This deviceK152790 Venus Versa SystemVenus Concept, Ltd. · 2016
Show all 10 generations
- Root · 10 generations backK910422 Model RD-1200 Ruby Laser SystemSpectrum Medical Technologies, Inc. · 1992
- 9 generations backK961279 Sharplan Lasers, Inc. Ruby Laser SystemSharplan Lasers, Inc. · 1996
- 8 generations backK962446 Sharplan Ruby Laser SystemSharplan Lasers, Inc. · 1997
- 7 generations backK974536 Photoderm HR SystemEsc Medical Systems, Ltd. · 1998
- 6 generations backK991935 Epilight Hair Removal System, Photoderm HR SystemEsc Medical Systems, Ltd. · 2000
- 5 generations backK020839 Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DLLumenis, Inc. · 2002
- 4 generations backK024093 Modified Lumenis Family of Intense Pulsed-Light (Ipl) and…Lumenis, Ltd. · 2003
- 3 generations backK043255 Ellipse Light SPTDanish Dermatologic Development A/S · 2005
- 2 generations backK052688 Ellipse Flex PPT, Model 9ESF7255Danish Dermatologic Development A/S · 2005
- 1 generation backK060516 Ellipse 12PL, Model 9ESL7228Danish Dermatologic Development A/S · 2006
- This deviceK152790 Venus Versa SystemVenus Concept, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | K910422 | Model RD-1200 Ruby Laser System | Spectrum Medical Technologies, Inc. | 1992 | — |
| −9 | K961279 | Sharplan Lasers, Inc. Ruby Laser System | Sharplan Lasers, Inc. | 1996 | — |
| −8 | K962446 | Sharplan Ruby Laser System | Sharplan Lasers, Inc. | 1997 | — |
| −7 | K974536 | Photoderm HR System | Esc Medical Systems, Ltd. | 1998 | — |
| −6 | K991935 | Epilight Hair Removal System, Photoderm HR System | Esc Medical Systems, Ltd. | 2000 | — |
| −5 | K020839 | Quantum, Models SR, HR, DL; Vasculight, Models SR, HR, VS, VX, DL | Lumenis, Inc. | 2002 | — |
| −4 | K024093 | Modified Lumenis Family of Intense Pulsed-Light (Ipl) and Combination Ipl… | Lumenis, Ltd. | 2003 | — |
| −3 | K043255 | Ellipse Light SPT | Danish Dermatologic Development A/S | 2005 | — |
| −2 | K052688 | Ellipse Flex PPT, Model 9ESF7255 | Danish Dermatologic Development A/S | 2005 | — |
| −1 | K060516 | Ellipse 12PL, Model 9ESL7228 | Danish Dermatologic Development A/S | 2006 | — |
| 0 (this device) | K152790 | Venus Versa System | Venus Concept, Ltd. | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 3 | 0 |
| 1993 | 3 | 0 |
| 1994 | 7 | 0 |
| 1995 | 6 | 0 |
| 1996 | 7 | 0 |
| 1997 | 6 | 0 |
| 1998 | 5 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2010 | 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 |
|---|---|---|---|
| * | K060516 | Ellipse 12PL, Model 9ESL7228Summary page 4…tology (21 CFR 878.4810), Product Code: ONF Predicate and Reference Devices Predicate Devices: Danish Dermatologic Development A/S’s Ellipse I2PL System (K060516) (Primary Predicate), MATTIOLI Pulse TWO/THREE Plus Family (K100053) Reference Devices: Alma Laser’s Harmony Lite… | 2006 |
| * | K100053 | Mattioli Pulse Two/Three Plus FamilySummary page 4…Devices Predicate Devices: Danish Dermatologic Development A/S’s Ellipse I2PL System (K060516) (Primary Predicate), MATTIOLI Pulse TWO/THREE Plus Family (K100053) Reference Devices: Alma Laser’s Harmony Lite Multi-Application Platform (K141237); Emvera Diolux (K123257); Lumen… | 2010 |
| † | K141237 | Harmony Lite | 2015 |
| † | K123257 | Emvera Diolux | 2012 |
| † | K053628 | Lightsheer Duet Laser System | 2006 |
| † | K143554 | Venus Legacy CX | 2015 |
| † | K041086 | Palomar Starlux Pulsed Light System | 2005 |
| † | K122995 | Intense Pulsed Light (Ipl) Systems | 2013 |
| † | K150051 | Exilite | 2015 |
| † | K113018 | Apollo V+ Medical Platform, Apollo IV+ Medical Platform, Nice Station Light Based Platform | 2012 |
| † | K113868 | Eplus Skin Treatment System | 2012 |
| † | K142376 | Palomar Icon Aesthetic System | 2014 |
| † | K063427 | Lumina Intense Pulsed Light (& Laser) System | 2007 |
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 24 years and passes through 7 companies; a new generation was cleared every 1.7 years on median.
- 2 of the 63 ancestors have a recall of any class.
- 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…
Read the full statement (135 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 and HR690 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K152790 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152790: 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/K152790
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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