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510(k) Data Aggregation
K Number
K241107Device Name
Indiba Diathermia Radiofrequency Deep Care Device (Deep care IDC0409/EVONY ); Indiba Diathermia Radiofrequency Activ Device (Activ ACT0309/CT9)
Manufacturer
INDIBA S.A.U
Date Cleared
2025-01-24
(277 days)
Product Code
PBX
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
INDIBA S.A.U
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Indiba Diathermia Radiofrequency Deep Care/Activ devices are intended to provide topical heating for the purpose of elevating tissue temperature for treatment of selected medical conditions such as: relief of pain, muscle spasms, increase in local circulation.
The massage device provided is intended to provide a temporary reduction in the appearance of cellulite.
Device Description
The INDIBA Diathermia Radiofrequency Activ device model (Activ CT9 device) and the INDIBA Diathermia Radiofrequency Deep Care device model (EVONY device), are noninvasive, diathermy, therapeutic devices, which employ RF current.
The device models consist of a console which generates a radiofrequency current which is delivered to the patient, in monopolar form, through two different types of electrodes, stainless steel conductive resistive electrodes (RES), and thin layer insulated capacitive electrodes (CAP). The electrodes are inserted into a handle, and the handle is connected to the console by a designated cable, the generated current flows through the patient and returns to the device through the neutral return electrode.
The Activ CT9 device model is equipped with additional massage applicators which provide mechanical massage for the temporary reduction in the appearance of cellulite.
The INDIBA Diathermia Radiofrequency Activ device model and the INDIBA Diathermia Radiofrequency Deep Care device model comprise a user interface (touchscreen) to facilitate the user device operation and to enable the user to predefine the device treatment settings.
The INDIBA Diathermia Radiofrequency Deep Care device model device incorporates smart handles and smart electrodes, which enables the device to automatically identify the connected applicators and enables their operation via the control options on the touchscreen.
The EVONY device provides a new temperature tracking tool enabling the user to track the patient skin temperature during the treatment time.
Improvements were performed in both device models in the console design and in the graphical user interface (GUI).
New applicators were introduced for the INDIBA Diathermia Radiofrequency Activ device model - the Fascia and Target electrodes and for the INDIBA Diathermia Radiofrequency Deep Care device model - the Sculpture electrodes. The new electrodes behave and operate in the same manner as the already FDA cleared RES and CAP electrodes.
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K Number
K243139Device Name
Reverso Pro System
Manufacturer
Indiba S.A.U
Date Cleared
2025-01-22
(114 days)
Product Code
GEI
Regulation Number
878.4400Why did this record match?
Applicant Name (Manufacturer) :
Indiba S.A.U
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
Intended Use
The Reverso Pro System is a non-invasive device intended to be used by aesthetic-related physicians or dermatologists. The Reverso Pro System utilizing the Reverso Applicator is a non-invasive device intended for use in dermatological procedures requiring ablation and resurfacing of the skin. The Reverso Pro System utilizing the Quadro RF Applicator is indicated to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The massage device is intended to provide a temporary reduction in the appearance of cellulite.
Device Description
The Reverso Pro System, positioned on a rolling cart, is a computerized system comprised of a console (main unit) and two Applicators: The Reverso Applicator with detachable single-use tips and the Quadro RF Applicator. The system using the Reverso Applicator delivers RF energy in a fractional manner to the skin of a treatment area for ablation and resurfacing of the skin, or using the Quadro RF Applicator in a continuous wave manner to provide topical heating for the purpose of elevating tissue temperature for the treatment of selected medical conditions such as temporary relief of pain, muscle spasms, and increase in local circulation. The Reverso Pro System provides individual adjustments of energy settings and treatment time, and, in the Reverso mode, it also enables the adjustment of tip pattern and pulse profile, to achieve appropriate efficiency and safety for each eligible patient. The system console includes a power supply unit, controller card and LCD screen with touch panel. The Reverso Pro System Applicators are designed for use in dermatological procedures, they are hand-held and ergonomically designed for the treatment requirements. The applicators are connected to the system via a separate cable, each. When not in use, the applicators can be placed within the applicator holder, where the Reverso Applicator is positioned on the system console and the Quadro RF Applicator is positioned on the rolling cart. The Reverso Applicator is compatible with five types of fractional RF tip heads: 44, 80, 88, 160 pin tip head and 176 pin tip head. The Quadro RF Applicator is emitting continues RF energy through a set of two pairs of stainless steel, RF electrodes. The applicator is hand-held and ergonomically designed to induce heat of the skin and beneath tissues for topical heating sensation.
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