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510(k) Data Aggregation

    K Number
    K212107
    Device Name
    Reverso
    Manufacturer
    Intelis Instruments Ltd.
    Date Cleared
    2021-11-10

    (127 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Why did this record match?
    Applicant Name (Manufacturer) :

    Intelis Instruments Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Reverso is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin.
    Device Description
    The Reverso device is a tabletop computerized system comprised a console (main unit) and Applicator with detachable single-use tips. The system delivers RF energy in a fractional manner to the skin of a treatment area for ablation and resurfacing of the skin. The Reverso device provides individual adjustments of energy settings, tip pattern, pulse profile to achieve appropriate efficiency and safety for each eligible patient. The device console includes a power supply unit, controller card and LCD screen with touch panel. The Reverso device Applicator is designed for use in dermatological procedures requiring ablation and resurfacing of the skin. The applicator is hand- held and ergonomically designed for the treatment requiring ablation and resurfacing of the skin. The applicator is connected to the system via a cable. When not in use, the applicator can be placed within the applicator holder positioned on the system console. The Reverso Applicator is compatible with two types of fractional RF tip heads; 80 pin tip head and 160 pin tip head.
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