Data / Medical devices / United States / Venus Concept Inc.
Venus Concept Inc.: FDA-registered device maker in Windham, NH, United States, 15 510(k) clearances
Venus Concept Inc. is registered with the FDA (registration 3042351542) in Windham, NH, United States. It lists 6 device types. The FDA files 15 510(k) clearances under its listings, the newest dated November 6, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3042351542
- Address
- 47 Enterprise Drive, Suite 216, Windham, NH, United States, 03087
- Owner or operator
- Venus Concept Inc. (10037692)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- September 1, 2021
- Registered through
- 2026
- Brand names listed
- Bliss Max, Venus Bliss, Venus Epileve, Venus Freeze (MP)2, Venus Heal, Venus Legacy, Venus Legacy BX, Venus Nova and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| November 6, 2025 | K252845 | Venus Nova (FP-2001) | GEI | Substantially Equivalent | Venus Concept, Inc. | accessdata.fda.gov |
| September 11, 2023 | K232192 | Venus Versa PRO System | ONF | Substantially Equivalent | Venus Concept, Inc. | accessdata.fda.gov |
| April 27, 2022 | K220592 | Venus BlissMAX | PBX | Substantially Equivalent | Venus Concept USA, Inc. | accessdata.fda.gov |
| June 26, 2020 | K201164 | Venus Viva MD Device | GEI | Substantially Equivalent | Venus Concept USA, Inc. | accessdata.fda.gov |
| June 9, 2020 | K200786 | Venus Epileve | GEX | Substantially Equivalent | Venus Concept USA, Inc. | accessdata.fda.gov |
| April 1, 2020 | K191065 | Venus VivaTM | GEI | Substantially Equivalent | Venus Concept USA, Inc. | accessdata.fda.gov |
| June 25, 2019 | K190743 | Venus Bliss | PBX | Substantially Equivalent | Venus Concept USA, Inc. | accessdata.fda.gov |
| February 1, 2019 | K182094 | Family of Venus RF Systems - Heal | PBX | Substantially Equivalent | Venus Concept USA, Inc. | accessdata.fda.gov |
| January 11, 2017 | K162765 | Venus Velocity Diode Laser System | GEX | Substantially Equivalent | Venus Concept , Ltd. | accessdata.fda.gov |
| March 21, 2016 | K153717 | Venus Versa System | ONF | Substantially Equivalent | Venus Concept , Ltd. | accessdata.fda.gov |
| January 20, 2016 | K152790 | Venus Versa System | ONF | Substantially Equivalent | Venus Concept , Ltd. | accessdata.fda.gov |
| August 4, 2015 | K143554 | Venus Legacy CX | PBX | Substantially Equivalent | Venus Concept , Ltd. | accessdata.fda.gov |
| May 12, 2015 | K150161 | Venus Viva SR Device | GEI | Substantially Equivalent | Venus Concept , Ltd. | accessdata.fda.gov |
| December 19, 2014 | K142910 | Legacy BX | GEI | Substantially Equivalent | Venus Concept USA, Inc. | accessdata.fda.gov |
| March 2, 2012 | K111670 | VENUS FREEZE (MP)2 SYSTEM | GEI | Substantially Equivalent | Venus Concept , Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Powered Laser Surgical Instrument
- All makers of Laser For Disruption Of Adipocyte Cells For Aesthetic Use
Updated November 6, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.