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510(k) Data Aggregation

    K Number
    K232192
    Device Name
    Venus Versa PRO System
    Manufacturer
    Venus Concept Inc.
    Date Cleared
    2023-09-11

    (49 days)

    Product Code
    ONF, GEI, GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Venus Concept Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Venus Versa PRO System is a multi-application device intended to be used in aesthetic and cosmetic procedures. The SR515 and SR580 IPL applicators are indicated for the following: · Treatment of benign pigmented epidermal and cutaneous lesions including: hyperpigmentation, melasma, ephelides (freckles), lentigines, nevi, and cafe-au-lait macules. · Treatment of benign cutaneous vascular lesions including port wine stains, hemangiomas, facial, truncal and leg telangiectasias, rosacea, angiomas, poikiloderma of civatte, leg veins and venous malformations. The HR650, HR650XL, and HR690XL IPL applicators are indicated for the removal of unwanted hair and to effect stable long-term or permanent hair reduction for skin types I-IV. Permanent hair reduction is defined as the longterm stable reduction in the number of hairs regrowing when measured at 6, 9, and 12 months after the completion of a treatment regimen. The Venus Concept ACDUAL applicator is intended to be used for the treatment of acne vulgaris. The Diamondpolar and Octipolar applicators are non-invasive devices intended for use in dermatologic and general surgery procedures for females for the non-invasive treatment of moderate to severe facial wrinkles in Fitzpatrick skin types I-IV. The Viva MD applicator is intended for dermatological procedures requiring ablation and resurfacing of the skin.
    Device Description
    The Venus Versa PRO System is comprised of a console (controller/CPU) and ten detachable handpieces (applicators) and two disposable tips. The system can deliver three types of energies to the patient's skin using the associated ten applicators: - Intense Pulsed Light (IPL) - Magnetic Pulse (MP2) - Radiofrequency (RF)
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