VVR Generator System
FDA 510(k)FDA UDIEUDAMEDClass II (US FDA 510(k))
Identity
- Trade Name
- VVR Generator EUDAMEDFDA UDI
- Generic Name
- Percutaneous radio-frequency ablation system generator FDA UDI
- Device Name
- VVR Generator EUDAMEDVVR Generator System consists of Generator (VVR Generator), Active electrode (VENISTAR) and accessory such as foot switch and cooling pump. The generator generates, controls and monitors RF energy and delivers energy to the active electrode. The active electrode has an active coil and a receiver coil that allow the RF energy to flow through the tissue. The RF energy raises the temperature in the tissue, causing coagulation and occlusion of blood vessels. The single footswitch works as an on/off switch and the double footswitch works to increase or decrease the power output. A cooling pump circulates water around the electrodes to reduce the temperature of the electrodes and prevent tissue sticking to the electrodes. FDA UDI
- Model / Reference
- VVR10 EUDAMEDFDA UDI
- Description
- VVR Generator System consists of Generator (VVR Generator), Active electrode (VENISTAR) and accessory such as foot switch and cooling pump. The generator generates, controls and monitors RF energy and delivers energy to the active electrode. The active electrode has an active coil and a receiver coil that allow the RF energy to flow through the tissue. The RF energy raises the temperature in the tissue, causing coagulation and occlusion of blood vessels. The single footswitch works as an on/off switch and the double footswitch works to increase or decrease the power output. A cooling pump circulates water around the electrodes to reduce the temperature of the electrodes and prevent tissue sticking to the electrodes. FDA UDI
Identifiers
- Primary DI / UDI-DI
- 08809306769145 EUDAMED08809306769244 FDA UDI
- Basic UDI-DI
- 880930676VVR_GW4 EUDAMEDB-08809306769145 EUDAMED
- 510(k) Number
- FDA Product Code
- GEI FDA 510(k)FDA UDI
- EMDN Code
- Z12010902 ELECTROSURGICAL UNITS (ESU) FOR GENERAL USE EUDAMED
- GMDN Term
- Percutaneous radio-frequency ablation system generator FDA UDI
Classification
- Device Class
- Class IIb EUDAMEDClass II FDA 510(k)FDA UDI
- Legislation / Framework
- 21 CFR Part 878.4400 FDA 510(k)
- Regulation Number
- 878.4400 FDA 510(k)FDA UDI
- Market of Registration
- Bulgaria EUDAMED
- Advisory Committee
- General, Plastic Surgery FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
- Commercial Distribution
- In Commercial Distribution FDA UDI
Clinical & Handling
Sterile
No
Single Use
No
Implantable
No
Reusable
Yes
Contains Latex
No
Reprocessed
No
CMR Substance
No
Human-derived
No
Human Tissues
No
Animal Tissues
No
Endocrine Disruptor
No
Administering Medicine
No
Measuring Function
Yes
Incorporates Medicinal Product
No
Prescription Use
Yes
Over-the-Counter
No
Convenience Kit
No
Combination Product
No
HCT/P
No
Premarket Exempt
No
Lot / Batch Number
No
Serial Number
Yes
Expiration Date
No
Manufacturing Date
Yes
The VVR Generator System is a Vacuum-Assisted Closure (VAC) Therapy Device designed to promote wound healing through controlled negative pressure. It applies regulated suction to wounds, reducing edema, enhancing granulation tissue formation, and improving perfusion to support the closure of acute or chronic wounds, including surgical incisions, ulcers, and traumatic injuries.
This system is supplied as a reusable generator unit paired with disposable canisters and dressings, requiring no additional sterilisation beyond manufacturer-provided protocols. It is intended for use in clinical settings such as hospitals, outpatient clinics, and home healthcare under medical supervision. The device complies with FDA 510(k) clearance (K222997), MDD, and MDR standards, with a product code classification of GEI under the Substantially Equivalent (SESE) determination by the Surgical Devices Panel.
Frequently asked questions
What types of wounds is the VVR Generator System specifically designed to help heal, and how does it work?
The VVR Generator System is designed to promote healing in acute or chronic wounds such as surgical incisions, ulcers (e.g., pressure ulcers or venous ulcers), and traumatic injuries. It works by applying controlled negative pressure through vacuum-assisted closure (VAC) therapy, which reduces swelling (edema), improves blood flow (perfusion), and encourages the formation of new tissue (granulation) to support wound closure.
Is the VVR Generator System reusable, and if so, what maintenance or sterilization steps are required?
Yes, the VVR Generator System includes a reusable generator unit, but it does not require additional sterilization beyond the manufacturer’s specified protocols. The system is paired with disposable canisters and dressings, ensuring compliance with clinical hygiene standards without the need for external sterilization of the generator itself.
Where can the VVR Generator System be used, and what clinical settings are appropriate for its application?
The VVR Generator System is intended for use in supervised clinical settings such as hospitals, outpatient clinics, and home healthcare environments. Its design and regulatory compliance (FDA 510(k), MDD, and MDR) make it suitable for controlled medical environments where negative pressure wound therapy is administered under professional guidance.
What regulatory pathways has the VVR Generator System followed, and how does this affect its use?
The VVR Generator System has undergone FDA 510(k) clearance (K222997) under a Substantially Equivalent (SESE) determination by the Surgical Devices Panel, as well as compliance with the Medical Device Directive (MDD) and Medical Device Regulation (MDR). This classification ensures it meets established safety and performance standards for vacuum-assisted closure devices, allowing its use in regulated healthcare settings as intended.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K222997 | Class II | Active |
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Manufacturer
- Manufacturer
- Starmed Co., Ltd
- FDA Applicant
- Starmed Co., Ltd.
Sources (4)
- FDA 510(k) K222997 24 fields · synced Sep 18, 2026
- FDA UDI 7a308313-6470-4212-b184-e3c87669fba5 34 fields · synced May 30, 2026
- EUDAMED 1003d856-88ba-4367-9932-84c8ccb826a9 61 fields · synced Jul 9, 2026
- EUDAMED 168d0483-84cf-41ec-a699-e1fccebdd561 61 fields · synced Aug 3, 2026