FDA Registration
Active
🇺🇸 United States
VENUS CONCEPT INC.
Reg #: 3006515340
·
FEI: 3006515340
·
Expires 2026
Products
9
Proprietary Names
12
Establishment Types
2
Classifications
9
Registration Details
- Registration Name
- VENUS CONCEPT INC.
- Registration Number
- 3006515340
- FEI Number
- 3006515340
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- No
- Address
- 1800 Bering Dr.
- City
- San Jose
- State
- CA
- ZIP
- 95112
- Country
- US
Regulatory Submissions
- 510(k) Number
- K153717
Owner / Operator
- Firm Name
- Venus Concept Inc.
- Operator Number
- 10037692
- Address
- 1800 Bering Drive
- City
- San Jose
- State
- CA
- Postal Code
- 95112
- Country
- US
- Correspondent
- Danielle Fulk
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Chair, Surgical, Non-Electrical | FZK | Class 1 | General, Plastic Surgery | No | 2018-02-08 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2025-11-17 |
| Stimulator, Muscle, Powered, For Muscle Conditioning | NGX | Class 2 | Physical Medicine | No | 2025-11-17 |
| Powered Microneedle Device | QAI | Class 2 | General, Plastic Surgery | No | 2023-02-07 |
| Laser For Disruption Of Adipocyte Cells For Aesthetic Use | PKT | Class 2 | General, Plastic Surgery | No | 2023-04-20 |
| Computer Assisted Hair Harvesting System | ONA | Class 2 | Neurology | No | 2018-11-09 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2021-09-01 |
Proprietary Names
ARTAS Patient Chair
Venus Versa
Venus Nova
Venus Legacy
Venus Viva
AIME System
Bliss Max
Venus Bliss
ARTAS iX
ARTAS System
Venus Velocity
Versa PRO
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device