Reverso Pro System

The Reverso Pro System is a non-invasive radiofrequency (RF) device intended for use by aesthetic physicians and dermatologists. It comprises a console with two interchangeable applicators: the Reverso Applicator delivers fractional RF energy for skin ablation and resurfacing, while the Quadro RF Applicator delivers continuous RF energy for topical heating to relieve pain, muscle spasms, and improve circulation, with an optional massage function for cellulite appearance reduction.

The Reverso Pro System uses fractional RF at 640 kHz (0.46 MHz) at up to 10 watts via multiple pin electrodes, and continuous bipolar RF at 1 MHz at up to 50 watts. The system includes five interchangeable fractional RF tip heads (44, 80, 88, 160, and 176 pins) and two sets of stainless steel bipolar electrodes for the Quadro applicator. Both applicators are hand-held, ergonomically designed, and connect via separate cables to the tabletop console containing power supply, controller, and LCD touchscreen interface.

The device was tested and complies with ANSI AAMI ES60601-1:2005/(R)2012 with amendments (general medical electrical equipment safety), IEC 60601-1-2 Edition 4.1 2020-09 (electromagnetic compatibility), IEC 60601-2-2 Edition 6.0 2017-03 (high-frequency surgical equipment), and IEC 60601-1-6 Edition 3.1 2013-10 (usability).

The Reverso Pro System shares identical RF performance specifications (frequency and energy output) with the primary predicate (Reverso Device, K212107) for fractional ablation indications, as demonstrated by bench testing. The Quadro RF applicator is substantially similar in design and mechanism to the secondary predicate's bipolar applicator (Venus Viva MD, K201164) for topical heating, and a tertiary predicate (InMode PLUS System, K172302) supports the same continuous RF heating indication. Bench and human skin testing confirmed the subject device maintains therapeutic temperatures equivalent to predicates, and all safety features and standards compliance are identical to or exceed those of predicates, with no new safety or effectiveness concerns identified.