Manufacturer
Viora , Ltd.V30 system, V-Form Handpiece BC Medium applicator
Country / Region:Israel (IL)Submission type:Traditional
Product code GEX· 21 CFR 878.4810
Product code
GEX
21 CFR 878.4810
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K162363
- Device name
- V30 system, V-Form Handpiece BC Medium applicator
- Company
- Viora , Ltd.
- Country / Region
- Israel(IL)
- Product code
- GEX
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4810
- Date received
- 2016-08-23
- Decision date
- 2016-11-18
- Submission type
- Traditional
- Technology type
- Other(AI inferred)
- Clinical applications
- Acne treatment
- Primary application
- Acne treatment
- Classification source
- AI classified
Indications for Use
The Viora V30 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-Nd:YAG Handpiece with wavelength 1064 nm comes with 4 different applicator spot diameters: 2x4, 3.5, 5.5 and 9.5 mm. The three smaller spot sizes (2x4, 3.5, 5.5 mm) are intended for: • Benign vascular lesions such as, but not limited to treatment of: port wine stains, hemangiomas, warts, superficial and deep telangiectasias (venulectasias), reticular veins (0.1-4.0 mm dia.) of the leg, rosacea, venus lake, leg veins, spider veins, poikiloderma of civatte and angiomas. • Benign cutaneous lesions, such as, but not limited to: warts, scars, striae and psoriasis. • Benign pigmented lesions such as, but not limited to: lentigos (age spots), solar lentigos (sun spots), cafe-au-lait macules, seborrheic keratosis, nevi and nevus of Ota, chloasma, verrucae, skin tags and keratosis. • Pigmented lesions to reduce lesion size, for patients with lesions that would potentially benefit from aggressive treatment, and for patients with lesions that have not responded to other laser treatments. • The non-ablative treatment of facial wrinkles, such as, but not limited to: periocular wrinkles and perioral wrinkles. The Handpiece with a spot size of 9.5 mm is also intended for treatment of: • Laser skin resurfacing procedures for the treatment of: acne scars and wrinkles. Reduction of red pigmentation in hypertrophic and keloid scars where vascularity is an integral part of the scar. • The Handpiece with a spot size of 9.5 mm is also intended for 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 and treatment of pseudofolliculitis barbae (PFB). The V-Form Handpiece (with BC Small, Medium and Large applicators) is indicated for delivering non-thermal RF combined with massage: • relief of minor muscle ach
Intended Use
The Viora V30 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 is indicated for the treatment of moderate inflammatory acne vulgaris, benign pigmented epidermal lesions, cutaneous lesions, benign cutaneous vascular lesions, and removal of unwanted hair. The V-Nd:YAG Handpiece is intended for various benign vascular and pigmented lesions, non-ablative treatment of facial wrinkles, and laser skin resurfacing procedures. The V-Form Handpiece is indicated for delivering non-thermal RF combined with massage for relief of minor muscle aches and pain, muscle spasm, temporary improvement of local blood circulation, and temporary reduction in the appearance of cellulite.
Device Description
The Viora V30 system is a multi-application, multi-technology platform device intended for use in dermatologic procedures. The main console unit incorporates a touch-screen control panel, power supply modules, cooling system, switching module and service panel. The system includes four Handpieces and footswitch. The V30 system is cooled by deionized water. The Viora V30 system is available with four treatment Handpieces: V-ST Handpiece (Bi-polar radiofrequency), V-IPL Handpiece (Intense pulsed light), V-ND:YAG Handpiece (Long pulse neodymium-doped yttrium aluminum laser), and V-Form Handpiece (with BC Small, BC Medium and BC Large applicators). The V-Form BC Medium applicator is a Bi-polar radiofrequency applicator supported by Viora's V10, V20 and V30 systems.
Summary parsed at:2026-06-01 06:06:56 UTC
Predicate devices
3—
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Not ingested
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Not ingested
V20 system
K162363 references 3 predicate/reference devices
Cited as predicate
0No later 510(k)s cite this device yet
Other submissions will appear here when they list K162363 as a predicate
