V20 system

Viora , Ltd.

Country / region:Israel (IL)Submission type:Traditional

Product code GEX· 21 CFR 878.4810

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Company

Israel (IL)

Product code

GEX
21 CFR 878.4810

Predicate devices

2

Cited as predicate

1

Device details

FDA 510(k) registration fields

K number
K152611
Device name
V20 system
Country / region
Israel(IL)
Product code
GEX
Device class
Class 2
Regulation number
21 CFR 878.4810
Date received
2015-09-14
Decision date
2016-02-19
Submission type
Traditional
Technology type
Other(AI inferred)
Clinical applications
Acne treatmentPigment treatment
Primary application
Acne treatment
Classification source
AI classified

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 415-1200nm (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 of 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.
- Temporary reduction in the appearance of cellulite.

Intended 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 415-1200nm (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 of 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.

Device Description

The Viora V20 system is a RF and IPL multi application platform with three available treatment Handpieces: V-ST Handpiece - Bi-polar radiofrequency (RF) Handpiece, V-IPL Handpiece - Intense Pulsed Light (IPL) Handpiece, V-Form Handpiece (with BC and FC applicators) – mechanical vacuum massage and Bi-polar radiofrequency (RF) Handpiece. The Main Unit (console) provides the operational and safety function of the system. The operator can modify the treatment parameters to achieve specific tissue effects depending on individual patient's skin condition and anatomical structure. The Foot Switch is used for system activation.

Summary parsed at:2026-06-01 06:05:09 UTC

Predicate devices

2

K152611 references 2 predicate/reference devices

Cited as predicate

1

1 submission cite K152611 as a predicate