# K152611: V20 system

- Pathway: 510(k) (Traditional)
- Applicant: Viora, Ltd.
- Decided: Feb 19, 2016 after 158 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: 20 generations back to K943450 (1995). 312 ancestors in all.
4 later devices descend from it; 4 cite it directly.
0 of 317 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.
- K150035: V10 system, Viora, Ltd. (2015) Summary page 4.

## Most influential descendants
- K162363: V30 system, V-Form Handpiece BC Medium applicator (2016), 3 descendants of its own
- K202247: V30 system, V20 system, V10 system, V-VR Hand piece (2020), 0 descendants of its own
- K201064: V30 System, V20 System, V10 System, V-FR Handpiece (2020), 0 descendants of its own
- K200468: V30 system, V20 system, V10 system, V-FC Handpiece (2020), 0 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. 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/K152611
Methodology: https://510kreport.com/methodology