Venus Nova (FP-2001)
FDA 510(k) K252845 · Venus Concept, Inc.
510(k) numberK252845
Submission
- Device name
- Venus Nova (FP-2001)
- Applicant
- Venus Concept, Inc.
San Jose, CA, US - Received
- September 8, 2025
- Decision date
- November 6, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- GEI – Electrosurgical, Cutting & Coagulation & Accessories
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4400
- Specialty
- General, Plastic Surgery
Validated reprocessing instructions and reprocessing validation data for this device type must be included in a 510(k) submission if the device is reusable and has specific design features (please refer to Table 2 of 82 FR 26807, available at https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
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| K253504 | VolnewmerGEI · Traditional | Classys, Inc. | 07/13/2026SE |
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| K260636 | Remanufactured LigaSure XP Maryland Jaw Sealer/Divider Without Nano-coatingGEI · Traditional | Stryker Sustainability Solutions | 06/18/2026SE |
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| 510(k) | Device | Decision |
|---|---|---|
| K232192 | Venus Versa PRO SystemONF · Special | 09/11/2023SE |
| K162765 | Venus Velocity Diode Laser SystemGEX · Traditional | 01/11/2017SE |
| K153717 | Venus Versa SystemONF · Traditional | 03/21/2016SE |
| K152790 | Venus Versa SystemONF · Traditional | 01/20/2016SE |
| K143554 | Venus Legacy CXPBX · Traditional | 08/04/2015SE |
| K150161 | Venus Viva SR DeviceGEI · Traditional | 05/12/2015SE |
| K140629 | Venus SWAN(MP)2GEI · Traditional | 06/25/2014SE |
| K111670 | Venus Freeze (MP)2 SystemGEI · Traditional | 03/02/2012SE |
| K111784 | Venus Swan SystemGEI · Traditional | 10/07/2011SE |
| K100586 | Venus Freeze SystemGEI · Traditional | 11/29/2010SE |
Questions and answers
When was Venus Nova (FP-2001) cleared by the FDA?
Venus Nova (FP-2001) (K252845) received a 510(k) decision of Substantially Equivalent on November 6, 2025, 59 days after the submission was received.
What is the product code of K252845?
The FDA product code is GEI – Electrosurgical, Cutting & Coagulation & Accessories, a Class II (moderate risk) device regulated under 21 CFR 878.4400.