Company ยท US
Venus Concept USA, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2010 to 2025. Name variants (Inc, Corp, punctuation) are merged.
22510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 6, 2025 | K252845 | Venus Nova (FP-2001) Venus Concept, Inc. | GEI |
| Sep 11, 2023 | K232192 | Venus Versa PRO System Venus Concept, Inc. | ONF |
| Dec 20, 2022 | K221011 | AI.ME System Venus Concept USA, Inc. | QAI |
| Apr 27, 2022 | K220592 | Venus BlissMAX Venus Concept USA, Inc. | PBX |
| Jan 12, 2022 | K213308 | Venus BlissMAX Venus Concept USA, Inc. | PBX |
| Oct 14, 2021 | K211461 | Family of Venus RF Systems - Venus Freedom Venus Concept USA, Inc. | PBX |
| Jun 26, 2020 | K201164 | Venus Viva MD Device Venus Concept USA, Inc. | GEI |
| Jun 9, 2020 | K200786 | Venus Epileve Venus Concept USA, Inc. | GEX |
| Apr 1, 2020 | K191065 | Venus VivaTM Venus Concept USA, Inc. | GEI |
| Sep 6, 2019 | K191528 | Venus Legacy Pro Device Venus Concept USA, Inc. | GEI |
| Jun 25, 2019 | K190743 | Venus Bliss Venus Concept USA, Inc. | PBX |
| Feb 1, 2019 | K182094 | Family of Venus RF Systems - Heal Venus Concept USA, Inc. | PBX |
| Jan 11, 2017 | K162765 | Venus Velocity Diode Laser System Venus Concept , Ltd. | GEX |
| Mar 21, 2016 | K153717 | Venus Versa System Venus Concept , Ltd. | ONF |
| Jan 20, 2016 | K152790 | Venus Versa System Venus Concept , Ltd. | ONF |
| Aug 4, 2015 | K143554 | Venus Legacy CX Venus Concept , Ltd. | PBX |
| May 12, 2015 | K150161 | Venus Viva SR Device Venus Concept , Ltd. | GEI |
| Dec 19, 2014 | K142910 | Legacy BX Venus Concept USA, Inc. | GEI |
| Jun 25, 2014 | K140629 | VENUS SWAN(MP)2 Venus Concept , Ltd., IL | GEI |
| Mar 2, 2012 | K111670 | VENUS FREEZE (MP)2 SYSTEM Venus Concept , Ltd., IL | GEI |
| Oct 7, 2011 | K111784 | VENUS SWAN SYSTEM Venus Concept , Ltd., IL | GEI |
| Nov 29, 2010 | K100586 | VENUS FREEZE SYSTEM Venus Concept , Ltd., IL | GEI |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||