# K200468: V30 system, V20 system, V10 system, V-FC Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Viora, Ltd.
- Decided: May 21, 2020 after 85 days
- Product code: PBX (Massager, Vacuum, Radio Frequency Induced Heat)
- Device class: 2
- Regulation: 21 CFR 878.4400
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 22 generations back to K943450 (1995). 314 ancestors in all.
No later device cites it as a predicate yet.
0 of 315 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K162363: V30 system, V-Form Handpiece BC Medium applicator, Viora, Ltd. (2016) Summary page 4.
- K152611: V20 system, Viora, Ltd. (2016) Summary page 4.
- K150035: V10 system, Viora, Ltd. (2015) Summary page 4.

## Indications for use
The Viora V10 system is intended for dermatological procedures. The V10 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, 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 Viora V20 system is intended for dermatological procedures. The V20 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, 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 Viora V30 system is intended for dermatological procedures. The V30 system with V-FC Handpiece is indicated for delivering non thermal RF combined with massage, 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.

Source page: https://510kreport.com/device/K200468
Methodology: https://510kreport.com/methodology