V30 System, V20 System, V10 System, V-FR Handpiece
FDA 510(k)Class II (US FDA 510(k))
by Viora Ltd
Identifiers
- 510(k) Number
- K201064 FDA 510(k)
- FDA Product Code
- PBX 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 V30 System, V20 System, and V10 System with V-FR Handpiece are fractional bipolar radiofrequency devices designed to deliver controlled RF energy for skin ablation and coagulation of the epidermis and superficial dermis. These systems are classified as Massagers, Vacuum, and Radio Frequency Induced Heat devices, primarily used in dermatological applications for skin resurfacing and treatment procedures.
The systems are supplied as reusable medical devices and are intended for use in clinical settings, with no indication of MRI compatibility or sterility requirements specified. Each system includes a handpiece (V-FR) compatible with the respective Viora platform (V10, V20, V30) and has received FDA 510(k) clearance under the Traditional pathway for General and Plastic Surgery applications. No specific size or storage instructions are detailed in the regulatory data.
Frequently asked questions
Are these devices intended for single-use or can they be reused in clinical settings?
The V30 System, V20 System, and V10 System with V-FR Handpiece are explicitly labeled as reusable medical devices. Since they are designed for clinical use in dermatological applications, they should be cleaned and maintained according to standard reprocessing protocols for reusable equipment. No specific sterility requirements are mentioned in the regulatory data, so adherence to facility-specific infection control guidelines is recommended.
What types of skin treatments are these systems primarily used for?
These systems are fractional bipolar radiofrequency devices intended for controlled RF energy delivery to the skin, specifically for skin ablation and coagulation of the epidermis and superficial dermis. They are classified under Massagers, Vacuum, and Radio Frequency Induced Heat devices, primarily used in dermatological applications for skin resurfacing and treatment procedures like general and plastic surgery interventions.
How do I determine which system (V30, V20, or V10) is compatible with the V-FR Handpiece?
The V-FR Handpiece is designed to be compatible with the Viora platform systems, meaning it can be used with the V10, V20, or V30 systems. The regulatory data does not specify differences in functionality or settings between the systems, so compatibility is assumed based on the manufacturer’s platform design. Always refer to the manufacturer’s instructions for specific pairing and usage guidelines.
Are there any special storage instructions provided for these devices?
The regulatory data for the V30, V20, and V10 Systems with V-FR Handpiece does not include specific storage instructions. Since these are reusable devices intended for clinical use, they should be stored in a clean, dry environment following standard protocols for reusable medical equipment. Ensure proper handling to prevent damage or contamination.
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: V30 System, V20 System, V10 System, V-FR Handpiece, V30 System, V20 System, V10 System, V-FR Handpiece by Viora Ltd. | FDA ..., V30 system, V20 system, V10 system, V-FC Handpiece (K200468) — FDA 510 ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K201064 | Class II | Active |
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Manufacturer
- Manufacturer
- Viora Ltd
- FDA Applicant
- Viora , Ltd.
Sources (1)
- FDA 510(k) K201064 24 fields · synced Sep 19, 2026