RIVIC, LLC

FDA Device Registration & Listing · Miami, FL, US · Registration 3030230686

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3030230686
FEI Number
3030230686
Entity Name
RIVIC, LLC
City/State/Country
Miami, FL, US
Establishment Address
460 NE 28th Street, Suite 503, Miami, FL 33137, US
Establishment Type(s)
Complaint File Establishment per 21 CFR 820.198
Owner / Operator
RIVIC, LLC (Owner Number: 10089419)
Owner / Operator Contact Address
460 NE 28th Street, Suite 503, Miami, FL 33137, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K233120
PMA Number
N/A

All Registered 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

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
PBX Massager, Vacuum, Radio Frequency Induced Heat General, Plastic Surgery Class 2 878.4400 2024-12-18
ONF Powered Light Based Non-Laser Surgical Instrument With Thermal Effect General, Plastic Surgery Class 2 878.4810 2024-12-16
QPB System, Suction, Lipoplasty For Removal General, Plastic Surgery Class 2 878.5040 2025-06-03
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-12-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2023-12-18
GEX Powered Laser Surgical Instrument General, Plastic Surgery Class 2 878.4810 2024-12-16
ONG Powered Laser Surgical Instrument With MicrobeamFractional Output General, Plastic Surgery Class 2 878.4810 2024-12-16
GEI Electrosurgical, Cutting & Coagulation & Accessories General, Plastic Surgery Class 2 878.4400 2025-05-19

Official Correspondent

No official correspondent registered.

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

RIVIC, LLC
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K192521 Shangdong Huamei Technology Co., Ltd. Intense Pulsed Light Treatment System 2019-12-06
K083258 Dornier Medtech America, Inc. MEDILAS D FAMILY LASERS, INCLUDING MEDILAS D LITEBEAM, LITEBEAM +, UROBEAM, MULTIBEAM, FLEXIPULSE AND MAGNAPULSE 2009-01-30
K201111 Candela Corporation GentleMax Pro Plus 2020-05-26
K202758 Shangdong Huamei Technology Co., Ltd. Nd: YAG Laser Therapy Systems HM-YL900 2020-11-16
K904068 Luxar Corp. LUXAR MODEL LX-20 CO2 LASER 1991-04-15

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0005-2014 PhotoMedex, Inc. 2
The product is labeled in part "***Surgical Laser Technologies, Inc. Montgomeryville, PA***SLT Fiber Delivery System***Sterile***Non-Pyrogenic***. The product is packaged in a flexible pouch and includes the following laser surgery accessories - SLT-SSRH 8, Catalog/Product Number 0041-3082; SLT-SSRH 11, Catalog/Product Number 0041-3112; SLT-SSRH 4-SMA, Catalog/Product Number 0042-0075; SLT-SSRH 5-SMA, Catalog/Product Number 0042-0076; SLT-SSRH 6-SMA, Catalog/Product Number 0042-0077; SLT-SSRH 7-SMA, Catalog/Product Number 0042-0078; SLT-SSRH 8-SMA, Catalog/Product Number 0042-0079; SLT-SSRH 9-SMA, Catalog/Product Number 0041-4931; and SLT-SSRH 10-SMA, Catalog/Product Number 0042-0081. Indicated for the incision, excision, coagulations, and vaporization of soft tissue.
Z-0025-2018 Medtronic Navigation, Inc. 2
VCLAS (Visualase Cooled Laser Ablation System) Part Number: 9735559 Visualase Cooled Laser Applicator System 3mm Tip; Part Number: 9735560 Visualase Cooled Laser Applicator System 10mm Tip; Part Number: 9735561 Visualase Cooled Laser Applicator System 15mm Tip
Z-0028-2007 Lumenis Inc. 2
Lumenis brand DuoTome SideLite 550 Micron Delivery System; laser systems for ablating soft tissue. Catalog Number: 0641-800-01; Manufactured by Lumenis, Inc., 2400 Condensa Street, Santa Clara, CA
Z-0031-06 Rita Medical Systems 2
Rita Brand Habib 4X Electrosurgical Coagulator, Catalog Number: 4401US; Product is distributed by RITA Medical Systems, Inc., One Horizon Way. Manchester, GA 32826

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030230686. Last updated year: 2026. Please use registration number 3030230686 when referencing this establishment in official correspondence.
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