Data / Medical devices / United States / Rivic, LLC
Rivic, LLC: FDA-registered device maker in Miami, FL, United States, 9 510(k) clearances
Rivic, LLC is registered with the FDA (registration 3030230686) in Miami, FL, United States. It lists 7 device types. The FDA files 9 510(k) clearances under its listings, the newest dated August 7, 2024. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3030230686
- Address
- 460 NE 28th Street, Suite 503, Miami, FL, United States, 33137
- Owner or operator
- RIVIC, LLC (10089419)
- Roles
- Complaint file establishment
- First device listed
- December 18, 2023
- Registered through
- 2026
- Brand names listed
- COLORMAX PLUS, COLORMAX PREMIUM (Q10, Q10 Premium) Q-Switched and Long-Pulsed Nd: YAG Laser, EMULSIFY (LIPOSAVER Suction Lipoplasty System), FIXER DB9 (CWM930S) RF Therapy System, FIXER DB9l (CWM-930S) Radio Frequency Therapy System, FRACLIGHT, FRACLIGHT PLUS (SHINY, SHINY PLUS) Micro Pulsed Laser System, HYDRASH (HYDRO QUEEN) Aqua Therapy System, IBLAZE (SMAXEL) Fractional CO2 Laser, REMOVALL TRIO (GP900 A8/Q8) Diode Laser System and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Brush, Dermabrasion, Powered | GFE | 1 | Complaint file establishment | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment | accessdata.fda.gov |
| Massager, Vacuum, Radio Frequency Induced Heat | PBX | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Laser Surgical Instrument | GEX | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Laser Surgical Instrument With MicrobeamFractional Output | ONG | 2 | Complaint file establishment | accessdata.fda.gov |
| Powered Light Based Non-Laser Surgical Instrument With Thermal Effect | ONF | 2 | Complaint file establishment | accessdata.fda.gov |
| System, Suction, Lipoplasty For Removal | QPB | 2 | Complaint file establishment | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 7, 2024 | K212969 | Liposaver | QPB | Substantially Equivalent | Lhbiomed Co., Ltd. | accessdata.fda.gov |
| May 23, 2024 | K233120 | CWM-930S, FIXER DV9 | GEI | Substantially Equivalent | Chungwoo Co., Ltd. | accessdata.fda.gov |
| March 29, 2023 | K222485 | SMARTRION COMBI/Alexandrite & Long Pulsed Nd:YAG Laser | GEX | Substantially Equivalent | Ids, Limited | accessdata.fda.gov |
| March 21, 2023 | K222709 | Retraction, CWM-910T, APOLEX Tite | GEI | Substantially Equivalent | Chungwoo Co., Ltd. | accessdata.fda.gov |
| December 22, 2021 | K213225 | Diode Laser System GP900A8, Diode Laser System GP900Q8 | GEX | Substantially Equivalent | Shenzhen Gsd Tech Co., Ltd. | accessdata.fda.gov |
| October 5, 2018 | K181868 | SHINY RPL System | ONF | Substantially Equivalent | Ids, Ltd. | accessdata.fda.gov |
| February 2, 2018 | K180036 | SMAXEL CO2 Surgical Laser System | ONG | Substantially Equivalent | Ids, Ltd. | accessdata.fda.gov |
| September 18, 2017 | K162828 | Winback Back 3SE | PBX | Substantially Equivalent | Winback USA Corp | accessdata.fda.gov |
| August 1, 2017 | K171079 | Q-Switched Nd:YAG Laser System | GEX | Substantially Equivalent | Ids, Ltd. | accessdata.fda.gov |
Compare with other makers
- All makers of System, Suction, Lipoplasty For Removal
- All makers of Powered Laser Surgical Instrument
- All makers of Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
- All makers of Massager, Vacuum, Radio Frequency Induced Heat
- All makers of Electrosurgical, Cutting & Coagulation & Accessories
- All makers of Brush, Dermabrasion, Powered
Updated August 7, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.