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The Viora V10 system is intended for dermatological procedures. The V10 system with the V-VR 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 Viora V20 system is intended for dermatological procedures. The V20 system with the V-VR 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 Viora V30 system is intended for dermatological procedures. The V30 system with the V-VR 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.

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. Cooled by deionized water based on the well-established bipolar radiofrequency (RF) technology used for heating of soft tissues. The main console unit incorporates a touch-screen control panel, power supply modules, RF generator and service panel. The V-VR Handpiece is supported by Viora's V10, V20 and V30 systems.

The Viora V10 system is intended for dermatological procedures. The V10 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin. The Viora V20 system is intended for dermatological procedures. The V20 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin. The Viora V30 system is intended for dermatological procedures. The V30 system with V-FR is indicated for dermatological procedures requiring ablation and resurfacing of the skin.

The V-FR Handpiece is fractional Bi-polar radiofrequency (RF) Handpiece is supported by Viora's V10, V20 and V30 systems. V30: 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. V20: dermatologic procedures. The main console unit incorporates a touch-screen control panel, power supply modules, cooling system, switching module and service panel. Cooled by deionized water V10: based on the well-established bipolar radiofrequency (RF) technology used for heating of soft tissues. The main console unit incorporates a touch-screen control panel, power supply modules, RF generator and service panel.

The Viora V10 system is intended for dermatological procedures. The V10 system with V-FC Handpiece 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. The Viora V20 system is intended for dermatological procedures. The V20 system with V-FC Handpiece 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. The Viora V30 system is intended for dermatological procedures. The V30 system with V-FC Handpiece 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.

The V-FC Handpiece is supported by Viora's V10, V20 and V30 systems. The V10, V20 and V30 systems are multi-application, multi-technology platform devices 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. Cooled by deionized water based on the well-established bipolar radiofrequency (RF) technology used for heating of soft tissues. The main console unit incorporates a touch-screen control panel, power supply modules, RF generator and service panel.

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, facial, truncal and leg telangiectasias, rosacea, erythema of rosacea, 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-tern 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: Y AG Handpiece with wavelength 1064 nm comes with 4 different applicator spot diameters: 2x4, 3.5 .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 (sun spots), cafe-aulait 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. 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 is 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 of pseudofollicultis 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 aches and pain, relief of muscle spasm, temporary improvement of local blood circulation and · temporary reduction in the appearance of cellulite. The Viora V20 and V10 systems with V-Form Handpiece (with BC Small, Medium and Large applicators) are 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.

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 (RF) Handpiece . - V-IPL Handpiece Intense pulsed light (IPL) Handpiece ● - V-ND:YAG Handpiece Long pulse neodymium-doped yttrium aluminum ● laser Handpiece - V Form Handpiece with BC Small, BC Medium and BC Large applicators . The V- Form BC Medium applicator is Bi-polar radiofrequency (RF) applicator. The applicator is supported by Viora's V10, V20 and V30 systems.

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, 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.

The Viora V20 system is a RF and IPL multi application platform with three available treatment Handpieces: V-ST Handpiece - Bi polar radiofrequency (RF) Handpieces 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.

The Viora V10 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-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.

The Viora V10 system is a RF multi application platform with two available treatment Handpieces: - V-ST Handpiece Bi-polar radiofrequency (RF) 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 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, 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 Viora V20 system is a RF and IPL multi application platform with two available treatment Handpieces: V-ST Handpiece: Bi polar radiofrequency (RF) Handpieces V-IPL Handpiece: Intense Pulsed Light (IPL) 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.

The V-Touch is intended for dermatological procedures. The ST applicator is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.

Viora's V-Touch system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The V-Touch system provides the treatments using the following speciallydesigned applicator: The ST applicator, which was cleared for Viora's Reaction system under K090221, utilizes RF bipolar energy, through 2 electrodes. It is used for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation.

The Viora V-total™ is intended for dermatological procedures. The ST handpiece is indicated for the treatment of relief of minor muscle aches and pain, relief of muscle spasm and temporary improvement of local blood circulation. The 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, rosace, erytherna 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 Nd: YAG Laser handpiece with wavelength 1064 mm comes with 4 different applicator spot diameters: 2x4, 3.5 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 telangiecasias (venulectasias), reticular veins (0.1-4.0 mm dia.) of the leg, rosseea, venus lake, leg 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 (sun spots), cale-aulait macules, sebortheic 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 is 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 of pseudofolioulitis barber (FFB).

The Viora V-total™ system is a multi application, multi-technology platform with four available treatment handpieces (applicators): - . ST Bi-polar radiofrequency (RF) handpiece - Intense pulsed light (IPL) handpiece . - Long pulse neodymium-doped yttrium aluminum (Nd:YAG) laser handpiece .

The Reaction™ system is intended for the treatment of the following medical conditions, using the B-contour and F-contour applicators 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. Using the ST applicator for delivering RF, the Reaction™ system is intended for the treatment of relief of minor musele aches and pain, relief of muscle spasm, temporary improvement of local blood circulation.

The Reaction™ system combines CORE™ (Channeling Optimized RF Energy) technology with mechanical vacuum massage of the skin. The Reaction™ treatment is indicated for the treatment of selected medical conditions such as relief of minor muscle aches and pain, relief of muscle spasm, temporary improvement of local blood circulation, temporary reduction in the appearance of cellulite The Reaction™ system provides the treatments using 3 specially-designed applicators that treat various areas of the body, including large and small areas. The system includes five core modules: the Console, the hand piece, and 3 treatment applicators: B-Contour, F-Contour and ST. The Reaction™ console houses the following components: - Power supply - Hand piece - Vacuum pump - RF Generator - Main CPU - Display unit The hand piece allows the operator to adjust the treatment parameters of the RF power and intensity of mechanical vacuum massage. The applicators incorporate operator panels and are used to adjust the treatment parameters of the RF power and mechanical vacuum manipulation.