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VIVA Combo RF System

FDA 510(k)

Class II (US FDA 510(k))

510(k) K252833

by Starmed Co., Ltd

Identifiers

510(k) Number
K252833 FDA 510(k)
FDA Product Code
GEI FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 878.4400 FDA 510(k)
Regulation Number
878.4400 FDA 510(k)
Advisory Committee
General, Plastic Surgery FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The VIVA Combo RF System is a radiofrequency ablation generator designed for percutaneous and intraoperative coagulation and ablation of soft tissue. It employs continuous radiofrequency output with real-time impedance feedback to ensure precise tissue treatment, reducing the risk of over-ablation during procedures.

This device is intended for use in clinical settings, including ultrasound-guided and endoscopic applications. Supplied as a reusable medical instrument, it is regulated under FDA 510(k) clearance (K252833) and falls under the General, Plastic Surgery advisory committee category. No specific sterility or single-use designation is stated in the provided data.

Frequently asked questions

What types of procedures is the VIVA Combo RF System designed to assist with, and how does it ensure precision during treatment?

The VIVA Combo RF System is designed for percutaneous (through-the-skin) and intraoperative (during surgery) coagulation and ablation of soft tissue. It uses continuous radiofrequency output with real-time impedance feedback, which helps clinicians monitor tissue response dynamically. This feature reduces the risk of over-ablation by adjusting power delivery based on tissue resistance, ensuring more controlled and precise treatment during procedures like ultrasound-guided or endoscopic applications.

Is the VIVA Combo RF System intended for single-use or reusable applications, and how should it be maintained?

The VIVA Combo RF System is supplied as a reusable medical instrument, meaning it is not designed for single-use. While the provided data does not specify sterilization requirements, reusable RF generators typically require proper cleaning, disinfection, and sterilization between uses to maintain performance and safety. Follow manufacturer guidelines for maintenance to ensure longevity and compliance with clinical standards.

What regulatory pathway was followed for the FDA clearance of the VIVA Combo RF System, and which advisory committee reviewed it?

The VIVA Combo RF System received FDA 510(k) clearance (K252833) under the Traditional 510(k) review pathway, determined to be *substantially equivalent* to a predicate device. The product was reviewed by the General, Plastic Surgery advisory committee (SU), which evaluates devices in these categories for safety and effectiveness before clearance.

Can the VIVA Combo RF System be used in both minimally invasive and open surgical settings, and what makes it versatile for different approaches?

Yes, the system is designed for both percutaneous (minimally invasive) and intraoperative (open surgery) applications, including ultrasound-guided and endoscopic procedures. Its adjustable radiofrequency output and real-time impedance feedback allow clinicians to adapt treatment parameters to different tissue types and surgical approaches, making it suitable for a range of interventions where precise coagulation or ablation is required.

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. Sources consulted: Radiofrequency Ablation Generator | STARMED America, STARMED VIVA COMBO RF SYSTEM MANUAL Pdf Download, VIVA Combo RF Generator System - TaeWoong Medical USA

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Starmed Co., Ltd
FDA Applicant
Starmed Co., Ltd.

Sources (1)

  • FDA 510(k) K252833 24 fields · synced Sep 19, 2026