# K142093: V20 System

- Pathway: 510(k) (Traditional)
- Applicant: Viora, Ltd.
- Decided: Nov 14, 2014 after 105 days
- Product code: GEX (Powered Laser Surgical Instrument)
- Device class: 2
- Regulation: 21 CFR 878.4810
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 18 generations back to K943450 (1995). 310 ancestors in all.
32 later devices descend from it; 2 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)
- K133837: Viora V-Total, Viora, Ltd. (2014) Summary page 4.

## Most influential descendants
- K150035: V10 system (2015), 31 descendants of its own
- 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

## Indications for use
The Viora V20 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-IPL Handpiece with wavelengths 415-l200nm (with 5 different filters) is indicated for the treatment of: • Moderate inflammatory acne vulgaris. • Benign pigmented epidermal lesions including dyschromia, hyperpigmentation, melasma, and ephelides (freckles). • Cutaneous lesions including warts, scars and striae. • Benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, angiomas and spider angiomas, poikiloderma of Civatte and venous malformations. • Removal unwanted hair. It is also intended for permanent reduction in unwanted hair. Permanent hair reduction is defined as the long-term stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen.

Source page: https://510kreport.com/device/K142093
Methodology: https://510kreport.com/methodology