FDA Registration
Active
🇮🇱 Israel
VENUS CONCEPT LTD.
Reg #: 3008915316
·
FEI: 3008915316
·
Expires 2026
Products
6
Proprietary Names
15
Establishment Types
2
Classifications
6
Registration Details
- Registration Name
- VENUS CONCEPT LTD.
- Registration Number
- 3008915316
- FEI Number
- 3008915316
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- Hamelacha 1 St.
- City
- Yokneam Illit Northern
- Country
- IL
Regulatory Submissions
- 510(k) Number
- K143554
Owner / Operator
- Firm Name
- Venus Concept Ltd.
- Operator Number
- 10036213
- Address
- Hamelacha 1 St.
- City
- Yokneam Illit
- State
- Northern
- Postal Code
- 2069812
- Country
- IL
- Correspondent
- Danielle Fulk
US Agent
- Business Name
- Venus Concept USA Inc
- Contact Name
- Slava Shubnikov
- Address
- 4001 Sw 47th Ave Ste 206
- City
- Davie
- State
- FL
- ZIP
- 33314
- Country
- US
- [email protected]
- Phone
- 888 9070115
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2015-09-03 |
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | Class 2 | General, Plastic Surgery | No | 2019-06-26 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2022-12-01 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2020-04-07 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2016-01-21 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2020-06-17 |
Proprietary Names
Legacy CX, Venus Legacy CX
Venus Heal
Venus Bliss
Venus BlissMAX
Venus Viva
Venus Viva SR Device
Venus Viva MD
Venus Versa
Legacy BX, Venus Legacy BX
Venus Legacy Pro
Venus Legacy
Venus Epileve
Venus Freeze Plus
Freeze (MP)2
Venus Freeze (MP)2
Establishment Types
Manufacture Medical Device
Develop Specifications But Do Not Manufacture At This Facility