# K201064: V30 System, V20 System, V10 System, V-FR Handpiece

- Pathway: 510(k) (Traditional)
- Applicant: Viora, Ltd.
- Decided: Jul 15, 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). 351 ancestors in all.
No later device cites it as a predicate yet.
0 of 352 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.
- K090025: Matrix RF Applicator, Syneron Medical, Ltd. (2010) Summary page 4.

## Indications for use
The Viora V10 system is intended for dermatological procedures. The V10 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin. The Viora V20 system is intended for dermatological procedures. The V20 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin. The Viora V30 system is intended for dermatological procedures. The V30 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.

Source page: https://510kreport.com/device/K201064
Methodology: https://510kreport.com/methodology