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510(k) Data Aggregation

    K Number
    K252367
    Device Name
    InbellaMulti System
    Manufacturer
    Inbella Medical Inc.
    Date Cleared
    2025-10-15

    (77 days)

    Product Code
    GEI
    Regulation Number
    878.4400
    Type
    Traditional
    Panel
    General & Plastic Surgery
    Reference & Predicate Devices
    K210492,K231790
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The InbellaMulti System with the Non-invasive Applicators employs RF energy for various applications:

    • i-BellaForma, BellaForma, BellaPlus and BellaPlus90 for relief of minor muscle aches and pain, relief of muscle spasm, and temporary improvement of local blood circulation.

    • BellaWMface is intended for use in dermatologic procedures for non-invasive treatment of mild to moderate facial wrinkles and rhytids.

    • BellaBodyFX /BellaMiniFX for 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 InbellaMulti System with the Fractional Applicators employs RF energy for various applications:

    • BellaFractora Applicator with 60 pins tip is designed for use in dermatological procedures requiring ablation and resurfacing of the skin.

    • BellaFractora Applicator with 24 pins tip is intended for use in dermatological and general surgical procedures for electrocoagulation and hemostasis. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

    • BellaM8 for dermatologic procedures where coagulation/contraction of soft tissue or hemostasis is needed. At higher energy levels greater than 62mJ/pin, use of the applicator is limited to skin types I-IV

    Device Description

    The InbellaMulti System supports multiple radiofrequency (RF) applications and accessories. The InbellaMulti System is compatible with the Fractional RF Applicators and the Non-Invasive RF Applicators, and employs RF energy for various applications. The InbellaMulti System consists of a platform console with an AC/DC power supply unit, two applicator connectors, RF generator, RF measuring circuit, controller, footswitch and user interface including a touch screen. The RF Applicator is connected to the console via a cable and a footswitch activates the energy delivery to the applicator. The applicators are comprised of a handle and electrodes, and some of them are used with a single-use tip. The below list comprises the set of applicators to be registered under the subject device:

    • i-BellaForma
    • BellaForma
    • BellaPlus
    • BellaPlus90
    • BellaWMFace
    • BellaBodyFX
    • BellaMiniFX
    • BellaFractora with 60 pins tip
    • BellaFractora with 24 pins tip
    • BellaM8 with the following tip heads: Resurfacing (T), Prime (12-pin), 24-pin, 40-pin (Body)
    AI/ML Overview

    N/A

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