Manufacturer
Viora , Ltd.V20 system
Country / Region:Israel (IL)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Device details
FDA 510(k) registration fields
- K number
- K152611
- Device name
- V20 system
- Company
- Viora , Ltd.
- 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
2Cited as predicate
1V30 system, V-Form Handpiece BC Medium applicator
1 submission cite K152611 as a predicate
