Manufacturer
Indiba S. A. U.Reverso Pro System
Country / Region:Spain (ES)Submission type:Traditional
Product code GEI· 21 CFR 878.4400
Product code
GEI
21 CFR 878.4400
Cited as predicate
0
Device details
FDA 510(k) registration fields
- K number
- K243139
- Device name
- Reverso Pro System
- Company
- Indiba S. A. U.
- Country / Region
- Spain(ES)
- Product code
- GEI
- Device class
- Class 2
- Regulation number
- 21 CFR 878.4400
- Date received
- 2024-09-30
- Decision date
- 2025-01-22
- Submission type
- Traditional
- Technology type
- RF Ablation(AI inferred)
- Clinical applications
- SurgeryPain ManagementOther
- Primary application
- Surgery
- Classification source
- AI classified
Indications for 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.
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. Following are the Reverso Pro System specifications: Dimension: 31.8cm W x 31.5cm D x 31.5cm H [12.4'' W x 12.3'' D x 12.3'' H] Weight: 6 Kg (13.2 lbs.) Main Line Frequency (nominal): 50-60 Hz Input Voltage (nominal): 100-240 VAC RF Max Output Power: 10 Watt - Fractional Reverso 50 Watt - Quadro RF RF Output Frequency: 640 KHz Fractional Reverso, 1 MHz Quadro RF.
Summary parsed at:2026-06-20 17:46:04 UTC
