# K162363: V30 system, V-Form Handpiece BC Medium applicator

- Pathway: 510(k) (Traditional)
- Applicant: Viora, Ltd.
- Decided: Nov 18, 2016 after 87 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: 21 generations back to K943450 (1995). 313 ancestors in all.
3 later devices descend from it; 3 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)
- K133837: Viora V-Total, Viora, Ltd. (2014) Summary page 5.
- K152611: V20 system, Viora, Ltd. (2016) Summary page 5.
- K150035: V10 system, Viora, Ltd. (2015) Summary page 5.

## Most influential descendants
- 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 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-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-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-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 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 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 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.

Source page: https://510kreport.com/device/K162363
Methodology: https://510kreport.com/methodology