Data / Medical devices / Israel / Venus Concept Ltd.
Venus Concept Ltd.: FDA-registered device maker in Yokneam Illit Northern, Israel, 15 510(k) clearances
Venus Concept Ltd. is registered with the FDA (registration 3008915316) in Yokneam Illit Northern, Israel. 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
- 3008915316
- Address
- Hamelacha 1 St., Yokneam Illit Northern, Israel, 2069812
- Owner or operator
- Venus Concept Ltd. (10036213)
- Roles
- Exporter to the US
- First device listed
- March 26, 2012
- Registered through
- 2026
- Brand names listed
- Freeze (MP)2, Legacy BX, Venus Legacy BX, Legacy CX, Venus Legacy CX, Venus Bliss, Venus BlissMAX, Venus Epileve, Venus Freeze (MP)2, Venus Freeze Plus and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Exporter to the US | accessdata.fda.gov |
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | 2 | Exporter to the US | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Exporter to the US | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Exporter to the US | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Exporter to the US | accessdata.fda.gov |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | 2 | Exporter to the US | 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 |
| 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 |
| September 6, 2019 | K191528 | Venus Legacy Pro Device | 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 Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Laser For Disruption Of Adipocyte Cells For Aesthetic Use
- All makers of Powered Laser Surgical Instrument
- All makers of Stimulator, Muscle, Powered, For Muscle Conditioning
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.