# K202247: V30 system, V20 system, V10 system, V-VR Hand piece

- Pathway: 510(k) (Traditional)
- Applicant: Viora, Ltd.
- Decided: Dec 9, 2020 after 121 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 the V-VR Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The Viora V20 system is intended for dermatological procedures. The V20 system with the V-VR Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation. The Viora V30 system is intended for dermatological procedures. The V30 system with the V-VR Handpiece is indicated for the temporary relief of minor muscle aches and pain, temporary relief of muscle spasm, and temporary improvement of local blood circulation.

Source page: https://510kreport.com/device/K202247
Methodology: https://510kreport.com/methodology