Venus Concept , Ltd.: FDA clearances and approvals
Venus Concept , Ltd. has 11 FDA 510(k) clearances (first 2010, latest 2025), across 4 product codes in 1 review panel. Median 510(k) review time: 108 days. Since 2017 its median was 59 days, against 101 days for all cleared 510(k)s in the same product codes. It is the industry lead sponsor of 24 device clinical trials on ClinicalTrials.gov.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 1 | 261 |
| 2013 | 0 | — |
| 2014 | 1 | 106 |
| 2015 | 2 | 170 |
| 2016 | 2 | 102 |
| 2017 | 1 | 103 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 49 |
| 2024 | 0 | — |
| 2025 | 1 | 59 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Venus Concept , Ltd.'s cleared 510(k)s took a median 59 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 101 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GEI | Electrosurgical, Cutting & Coagulation & Accessories | 6 | 6 |
| ONF | Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | 3 | 3 |
| GEX | Powered Laser Surgical Instrument | 1 | 1 |
| PBX | Massager, Vacuum, Radio Frequency Induced Heat | 1 | 1 |
Review panels
Most recent Venus Concept , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252845 | Venus Nova (FP-2001) | GEI | 2025-11-06 | 59 |
| K232192 | Venus Versa PRO System | ONF | 2023-09-11 | 49 |
| K162765 | Venus Velocity Diode Laser System | GEX | 2017-01-11 | 103 |
| K153717 | Venus Versa System | ONF | 2016-03-21 | 88 |
| K152790 | Venus Versa System | ONF | 2016-01-20 | 117 |
| K143554 | Venus Legacy CX | PBX | 2015-08-04 | 232 |
| K150161 | Venus Viva SR Device | GEI | 2015-05-12 | 109 |
| K140629 | VENUS SWAN(MP)2 | GEI | 2014-06-25 | 106 |
| K111670 | VENUS FREEZE (MP)2 SYSTEM | GEI | 2012-03-02 | 261 |
| K111784 | VENUS SWAN SYSTEM | GEI | 2011-10-07 | 108 |
1 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Venus Concept , Ltd..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Device clinical trials
Venus Concept , Ltd. is the industry lead sponsor of 24 device studies on ClinicalTrials.gov (2 active or recruiting). Most recent:
- NCT05256771: Electrical Muscle Stimulation with 1064 Nm Diode Laser and RF/PEMF for Non-invasive Body Contouring and Fat Reduction. (Active not recruiting, started 2021-11-01)
- NCT04827680: Clinical Evaluation of the Safety and Performance of FRF for the Treatment and Reduction of Acne Scarring (Completed, started 2021-05-01)
- NCT04616898: Analysis of the Performance of 1060 nm Diode and Radio Frequency Prior to Abdominoplasty (Completed, started 2020-07-01)
- NCT04012814: Clinical Evaluation of a 1060 nm Diode Laser, PEMF and Vacuum Assisted MP RF for Non-invasive Fat Reduction (Completed, started 2019-09-19)
- NCT04210583: RF and PEMF for Treatment of Vaginal Laxity and Mons Pubis and Labia for Improvement of Skin Laxity (Completed, started 2019-09-04)
Frequently asked questions
How many FDA 510(k) clearances does Venus Concept , Ltd. have?
Venus Concept , Ltd. has 11 FDA 510(k) clearances (first 2010, latest 2025), across 4 product codes in 1 review panel.
How long does FDA take to clear Venus Concept , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Venus Concept , Ltd.'s cleared 510(k)s is 108 days. Since 2017: 59 days, versus 101 days for all cleared 510(k)s in the same product codes.
What devices does Venus Concept , Ltd. make?
Its most frequent FDA product codes are GEI (Electrosurgical, Cutting & Coagulation & Accessories, 6); ONF (Powered Light Based Non-Laser Surgical Instrument With Thermal Effect, 3); GEX (Powered Laser Surgical Instrument, 1).
Has Venus Concept , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Venus Concept , Ltd. Related entities may recall under other names.
Next steps
- See all 11 Venus Concept , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code GEI, Venus Concept , Ltd.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.