SPECCHIO

The SPECCHIO is a medical device that uses high-frequency RF currents at 2.45 GHz to generate localized heating in subcutaneous tissue for temporary relief of pain, muscle spasms, and increased local circulation. It also includes integrated mechanical massage handpieces designed to temporarily reduce the appearance of cellulite.

The device operates at 200W maximum RF output power in bipolar mode, maintaining an effective temperature of 40–43°C. It features three interchangeable handpieces (Deep PRO 66 mm, Shallow PRO 56 mm, and Pocket PRO 36.5 mm) with contact quality monitoring and a contact quality monitoring system, compared to the predicate's two larger handpieces (78 mm and 68 mm).

Testing included ANSI AAMI ES60601-1, IEC 60601-1-2, IEC 60601-2-6:2012+A1:2016 for electrical safety and electromagnetic compatibility. Non-clinical testing on ex-vivo animal tissue verified temperature maintenance at 40–43°C. Software validation and verification followed FDA guidance for device software functions.

The SPECCHIO is substantially equivalent to the predicate DEKA TIAC II (K211091) because it has identical indications for use, regulatory classification, product code, RF technology, frequency, power output, and temperature range. The modifications (cosmetic restyling and handpiece engineering with interchangeable heads) do not affect safety or efficacy, and technical specifications remain within the predicate device's range.