Venus Concept Inc.
San Jose, CA, US
VENUS CONCEPT INC. appears in FDA device records in San Jose, CA. FDA records list 15 510(k) clearances between and , no PMA records and 3 registered establishments. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
FDA records under these names
1 nameFDA records resolved to Venus Concept Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.
- Restoration Robotics, Inc.510(k), enforcement report, recall
510(k) clearance history
FDA records hold 15 510(k) clearances for Venus Concept Inc. between 2010 and 2025. The busiest year on record is 2011, with 2. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 2010 | 1 |
| 2011 | 2 |
| 2012 | 1 |
| 2013 | 2 |
| 2014 | 1 |
| 2015 | 2 |
| 2016 | 2 |
| 2017 | 1 |
| 2018 | 1 |
| 2023 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K252845 | Venus Nova (FP-2001) | GEI | Substantially Equivalent | |
| K232192 | Venus Versa PRO System | ONF | Substantially Equivalent | |
| K173358 | ARTAS System | ONA | Substantially Equivalent | |
| K162765 | Venus Velocity Diode Laser System | GEX | Substantially Equivalent | |
| K153717 | Venus Versa System | ONF | Substantially Equivalent | |
| K152790 | Venus Versa System | ONF | Substantially Equivalent | |
| K143554 | Venus Legacy CX | PBX | Substantially Equivalent | |
| K150161 | Venus Viva SR Device | GEI | Substantially Equivalent | |
| K140629 | VENUS SWAN(MP)2 | GEI | Substantially Equivalent | |
| K123548 | THE ARTAS SYSTEM | ONA | Substantially Equivalent | |
| K123154 | ARTAS SYSTEM FROM RESTORATION ROBOTICS | ONA | Substantially Equivalent | |
| K111670 | VENUS FREEZE (MP)2 SYSTEM | GEI | Substantially Equivalent | |
| K111784 | VENUS SWAN SYSTEM | GEI | Substantially Equivalent | |
| K103428 | THE ARTAS SYSTEM FROM RESTORATION ROBOTICS | ONA | Substantially Equivalent | |
| K100586 | VENUS FREEZE SYSTEM | GEI | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 3006515340 | 3006515340 | VENUS CONCEPT INC. | 1800 Bering Dr., San Jose, CA 95112 US | 2026 | |
| 3008915316 | 3008915316 | VENUS CONCEPT LTD. | Hamelacha 1 St., Yokneam Illit Northern 2069812 IL | 2026 | |
| 3042351542 | 3042351542 | Venus Concept Inc. | 47 Enterprise Drive, Suite 216, Windham, NH 03087 US | 2026 |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- FZKChair, Surgical, Non-Electrical
- ONAComputer Assisted Hair Harvesting System
- GEIElectrosurgical, Cutting & Coagulation & Accessories
- PKTLaser For Disruption Of Adipocyte Cells For Aesthetic Use
- PBXMassager, Vacuum, Radio Frequency Induced Heat
- GEXPowered Laser Surgical Instrument
- ONFPowered Light Based Non-Laser Surgical Instrument With Thermal Effect
- QAIPowered Microneedle Device
- NGXStimulator, Muscle, Powered, For Muscle Conditioning
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| Z-0356-2014 | ARTAS Disposable and Reuseable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; dissection Punch 4.0mm FP 23304; Saline Nose Cone FP-45387; Follicle Trap FP 23306; Non-Sterile Disposable kit FP 23267 and Molded Parts, Reusable Kit FP 45538 Rx): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. | Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine. | Class II | Terminated | |
| Z-0355-2014 | Sterile Disposable Kit ( Contains Skin Tensioner ASY-25067; Three Mark Needle Assembly ASY-25094; Nose Cone Assembly ASY-25098; Dissection 4 mm PRT-25117, follicle Trap PRT 23999): Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. | Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine. | Class II | Terminated | |
| Z-0354-2014 | ARTAS Disposable Kit ( Contains Skin Tensioner FP-45384; Inner Needle with Vacuum Tube FP-45385; Dissection Punch 4.0mm FP-23304; Saline Nose Cone FP-45387; Follicle Trap - FP-23306 and Non-sterile Disposable Clinical Kit FP -23267): and ARTAS Disposable Kits, 18 Gauge Epsilon (Contains Disposable Kit, 18 Gauge Epsilon FP 45547 and Non-Sterile Disposable Kit FP-23267). RX. Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. | Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine. | Class II | Terminated | |
| Z-0353-2014 | Epsilon Skin Tensioner:Rx, Sterile Sterilized using Gamma. Turns Red if sterilized using Gamma; Product Usage: Skin Tensioner is applied to patients scalp during follicular harvesting during hair restoration procedure. Product applies tension to scalp to facilitate follicular extractions. | Reports of discoloration (residue) on the pins of the skin tensioner have been received by several customers. Discoloration due to insufficient cleaning of stainless steel pins during passivation process. The residue has been identified as a compound of iron and chlorine. | Class II | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain