Star RF Electrode, VIVA RF Electrode
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172012 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 Star RF Electrode and VIVA RF Electrode are radiofrequency (RF) electrodes designed for use in plastic surgery procedures. These devices are intended to deliver controlled thermal energy to tissue, facilitating procedures such as skin tightening, fat reduction, and contouring through precise RF ablation.
The electrodes are supplied sterile and intended for single-use. They are classified under the product code GEI and are authorized under FDA 510K clearance, MDD, and MDR regulations. The devices are manufactured by Starmed Co., Ltd., and are intended for use in controlled clinical settings where radiofrequency energy is applied under professional supervision.
Frequently asked questions
What types of plastic surgery procedures are these RF electrodes designed to assist with, and how do they work?
The Star RF Electrode and VIVA RF Electrode are specifically designed for procedures like skin tightening, fat reduction, and body contouring. They deliver controlled thermal energy to targeted tissue through radiofrequency (RF) ablation, which helps achieve precise results in these cosmetic applications. The electrodes are intended for use under professional supervision in controlled clinical settings.
Are these electrodes intended for single-use or can they be reused after sterilization?
These electrodes are explicitly supplied sterile and intended for single-use only. The manufacturer does not recommend or support reuse, even after sterilization, as this could compromise safety and performance. Always follow the manufacturer’s instructions for proper disposal after one use.
What regulatory pathways have these RF electrodes undergone, and how does that affect their use?
The Star RF Electrode and VIVA RF Electrode have undergone FDA 510(k) clearance, as well as authorization under the Medical Device Directive (MDD) and Medical Device Regulation (MDR). This means they meet regulatory standards for safety and effectiveness in their intended applications, but their use must comply with local healthcare regulations and professional guidelines. Always verify compliance with your region’s requirements before implementation.
What sizes or models of these RF electrodes are available, and how are they differentiated?
The provided data does not specify exact sizes or model variations (e.g., electrode tip shapes, lengths, or power settings) for the Star RF Electrode or VIVA RF Electrode. However, they are both classified under the FDA product code GEI (Electrosurgical Devices) and are designed for plastic surgery procedures. For precise sizing or model details, refer to the manufacturer’s technical documentation or contact Starmed Co., Ltd. directly.
How should these electrodes be stored to maintain their sterility and performance?
Since these electrodes are supplied sterile and intended for single-use, they should be stored in their original, unopened packaging in a clean, dry environment away from direct sunlight or extreme temperatures. Avoid contamination by keeping them sealed until immediately before use. Always check the packaging for expiration dates or integrity before proceeding with a procedure.
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 | K172012 | Class II | Active |
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Manufacturer
- Manufacturer
- Starmed Co., Ltd
- FDA Applicant
- Starmed Co., Ltd.
Sources (2)
- FDA 510(k) K172012 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 28, 2026