RIVIC, LLC
Registration 3030230686FEI 3030230686Miami, FL
Owner/operator: RIVIC, LLC
- Complaint File Establishment per 21 CFR 820.198
Renewal due by December 31, 2026
Registered through 2026. Renew between October 1 and December 31, 2026, to stay registered for 2027.
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The 2026 window
- Oct 1Window opens91 days left
- Nov 3Where you stand58 days left
- Dec 1Our pay-by date30 days left
- Dec 15Two weeks left16 days left
- Dec 23Holiday week8 days left
- Dec 29Two days left2 days left
- Dec 31Window closes0 days left
- FDA fee, FY2027
- $13,785
- Our pay-by suggestion
- Dec 1
- Listed devices
- 11
- Added, last 12 months
- 0
FDA sets who pays the fee and who may qualify for a waiver; its fee page says so. The fee is paid only on FDA’s own fee site. Never through us. FDA’s fee page
The steps, in order
Pay FDA's annual feeYou
Order and pay the FY2027 establishment fee on FDA's Device Facility User Fee site. FDA emails you a PIN when you order.
FDA: registration and listing payment processWait for the payment confirmation numberYou
FDA emails a Payment Confirmation Number (PCN) once the payment processes, which FDA says typically takes several days. That is why we suggest paying by December 1.
FDA: registration and listing payment processRenew the registration in FDA's systemYou
Sign in to FDA's Unified Registration and Listing System (FURLS), complete the annual registration and apply your PIN and PCN. FDA does not count the registration as complete until both are applied.
FDA: device registration and listingReview every listingYou
In the same window, review each listing on file and report any changes, deletions and new listings. Your Listing Review Sheet puts every listing on one page.
FDA: device registration and listing
Every listed device 11
| Code | Device | Class | Regulation | Premarket |
|---|---|---|---|---|
| GEI | FIXER DB9 (CWM930S) RF Therapy SystemElectrosurgical, Cutting & Coagulation & Accessories | Class 2 | 21 CFR 878.4400 | K233120 |
| GEI | FIXER DB9l (CWM-930S) Radio Frequency Therapy SystemElectrosurgical, Cutting & Coagulation & Accessories | Class 2 | 21 CFR 878.4400 | K222709 |
| PBX | TENSAMAX PRO (WinBack Back 3SE)Massager, Vacuum, Radio Frequency Induced Heat | Class 2 | 21 CFR 878.4400 | K162828 |
| GEX | IBLAZE (SMAXEL) Fractional CO2 LaserPowered Laser Surgical Instrument | Class 2 | 21 CFR 878.4810 | K180036 |
| GEX | REMOVER (Smartrion Combi)Powered Laser Surgical Instrument | Class 2 | 21 CFR 878.4810 | K222485 |
| GEX | COLORMAX PLUS, COLORMAX PREMIUM (Q10, Q10 Premium) Q-Switched and Long-Pulsed Nd: YAG LaserPowered Laser Surgical Instrument | Class 2 | 21 CFR 878.4810 | K171079 |
| GEX | REMOVALL TRIO (GP900 A8/Q8) Diode Laser SystemPowered Laser Surgical Instrument | Class 2 | 21 CFR 878.4810 | K213225 |
| ONG | IBLAZE (SMAXEL) Fractional CO2 LaserPowered Laser Surgical Instrument With MicrobeamFractional Output | Class 2 | 21 CFR 878.4810 | K180036 |
| ONF | FRACLIGHT, FRACLIGHT PLUS (SHINY, SHINY PLUS) Micro Pulsed Laser SystemPowered Light Based Non-Laser Surgical Instrument With Thermal Effect | Class 2 | 21 CFR 878.4810 | K181868 |
| QPB | EMULSIFY (LIPOSAVER Suction Lipoplasty System)System, Suction, Lipoplasty For Removal | Class 2 | 21 CFR 878.5040 | K212969 |
| GFE | HYDRASH (HYDRO QUEEN) Aqua Therapy SystemBrush, Dermabrasion, Powered | Class 1 | 21 CFR 878.4820 | — |
What changed
Nothing added in the last twelve months, and no change seen on the record yet.