FDA Registration
Active
🇺🇸 United States
RIVIC, LLC
Reg #: 3030230686
·
FEI: 3030230686
·
Expires 2026
Products
7
Proprietary Names
12
Establishment Types
1
Classifications
7
Registration Details
- Registration Name
- RIVIC, LLC
- Registration Number
- 3030230686
- FEI Number
- 3030230686
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 460 NE 28th Street, Suite 503
- City
- Miami
- State
- FL
- ZIP
- 33137
- Country
- US
Regulatory Submissions
- 510(k) Number
- K162828
Owner / Operator
- Firm Name
- RIVIC, LLC
- Operator Number
- 10089419
- Address
- 460 NE 28th Street, Suite 503
- City
- Miami
- State
- FL
- Postal Code
- 33137
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | Class 2 | General, Plastic Surgery | No | 2024-12-18 |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | Class 2 | General, Plastic Surgery | No | 2024-12-16 |
| System, Suction, Lipoplasty For Removal | QPB | Class 2 | General, Plastic Surgery | No | 2025-06-03 |
| Powered Laser Surgical Instrument | GEX | Class 2 | General, Plastic Surgery | No | 2024-12-16 |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | Class 2 | General, Plastic Surgery | No | 2023-12-18 |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | Class 2 | General, Plastic Surgery | No | 2024-12-16 |
| Brush, Dermabrasion, Powered | GFE | Class 1 | General, Plastic Surgery | No | 2024-12-16 |
Proprietary Names
TENSAMAX PRO (WinBack Back 3SE)
FRACLIGHT, FRACLIGHT PLUS (SHINY, SHINY PLUS) Micro Pulsed Laser System
EMULSIFY (LIPOSAVER Suction Lipoplasty System)
REMOVALL TRIO (GP900 A8/Q8) Diode Laser System
Retraction Apolex Tite
FIXER DB9l (CWM-930S) Radio Frequency Therapy System
TENTREK
IBLAZE (SMAXEL) Fractional CO2 Laser
FIXER DB9 (CWM930S) RF Therapy System
REMOVER (Smartrion Combi)
COLORMAX PLUS, COLORMAX PREMIUM (Q10, Q10 Premium) Q-Switched and Long-Pulsed Nd: YAG Laser
HYDRASH (HYDRO QUEEN) Aqua Therapy System
Establishment Types
Complaint File Establishment per 21 CFR 820.198