# K150035: V10 system

- Pathway: 510(k) (Traditional)
- Applicant: Viora, Ltd.
- Decided: May 1, 2015 after 112 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: 19 generations back to K943450 (1995). 311 ancestors in all.
31 later devices descend from it; 10 cite it directly.
0 of 343 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K142093: V20 System, Viora, Ltd. (2014) Summary page 4.
- K090221: Reaction System, Viora, Ltd. (2009) Summary page 4.

## Most influential descendants
- K153568: InMode Plus System (2016), 18 descendants of its own
- K172302: InMode PLUS System (2017), 13 descendants of its own
- K183450: EmBody System (2019), 8 descendants of its own
- K201285: InMode Evolve System with the Tone Applicator (2021), 6 descendants of its own
- K210877: Evolve System with the T3 Applicator (2021), 5 descendants of its own

## Indications for use
The Viora V10 system is intended for dermatological procedures. The V-ST 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 V-Form Handpiece (with BC and FC applicators) 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/K150035
Methodology: https://510kreport.com/methodology