Identifiers
- 510(k) Number
- K150035 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 V10 system is a massager that delivers non-thermal radio frequency combined with massage. It is intended for dermatological procedures and is indicated for the relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
The V10 system is manufactured by Viora Ltd. and has received FDA 510(k) clearance with the product code PBX. The system is supplied with various handpieces including the V-FC Handpiece (K200468), V-ST Handpiece, and V-Form Handpiece. It is regulated as a Class II device and is intended for use in general and plastic surgery applications.
Frequently asked questions
What is the V10 system used for?
The V10 system is a massager that delivers non-thermal radio frequency combined with massage. It is intended for dermatological procedures and is indicated for relief of minor muscle aches and pain, muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
What handpieces are included with the V10 system?
The V10 system is supplied with various handpieces including the V-FC Handpiece (K200468), V-ST Handpiece, and V-Form Handpiece. These handpieces are designed to provide different treatment options for various dermatological and plastic surgery applications.
What is the regulatory status of the V10 system?
The V10 system has received FDA 510(k) clearance with the product code PBX. It is regulated as a Class II device and is intended for use in general and plastic surgery applications. The clearance was granted on May 1, 2015, with the K number K150035.
Is the V10 system reusable or single-use?
The device data does not specify whether the V10 system is designed for single-use or multiple uses. However, as a Class II medical device with multiple handpieces, it appears to be designed for repeated clinical use rather than single-use disposal.
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-FC Handpiece (K200468) — FDA 510 ..., V10 system by VIORA LTD. | FDA 510 (k) Summary, Viora V10 Multi-Technology Platform System - Medical XPRT
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K150035 | Class II | Active |
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Manufacturer
- Manufacturer
- Viora Ltd
- FDA Applicant
- Viora , Ltd.
Sources (1)
- FDA 510(k) K150035 24 fields · synced Sep 25, 2026