Sensilift Pro (ST300XXYYZZZ)

The Sensilift Pro is an over-the-counter, home-use radiofrequency (RF) device designed for non-invasive treatment of mild to moderate facial wrinkles in adults with Fitzpatrick skin types I–IV. The hand-held device emits 1 MHz RF energy to heat facial tissue, with a maximum temperature limit of 40±0.5°C and maximum power output of 6±1 Watt. Treatment involves 5 minutes per area, once weekly for 8 consecutive weeks.

The device operates at 1 MHz RF frequency (bi-polar configuration) with 2 electrodes, 176 mm² treatment area per electrode, 3 user-selectable energy levels (3.5, 5, and 6 Watts), dual redundant thermistors for temperature control, rechargeable battery, and compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-2 safety standards. It differs from Sensilift (predicate 1) in cordless design and from Pollogen STOP U (predicate 2) in having 2 electrodes versus 4, and 3 energy levels versus 2.

IEC 60601-1:2005/2024; IEC 60601-1-2:2014; IEC 60601-1-11:2015; IEC 60601-2-2:2017; ISO 10993-1:2018, ISO 10993-5:2009, ISO 10993-10:2021 (biocompatibility); FDA guidance on software V&V (Basic level) and cybersecurity risk management (Low overall risk).

Sensilift Pro is substantially equivalent to predicate devices because it shares identical regulatory classification (Class II, PAY, 21 CFR 878.4420), intended use (OTC home-use RF wrinkle reduction for Fitzpatrick I–IV), anatomical sites, treatment regimen, energy source (1 MHz RF), body-contact materials (ABS plastic, chrome electrodes), and safety standards compliance. Minor differences in handpiece size, weight, LED indicators, and cordless operation do not raise new safety or effectiveness concerns and are supported by equivalent performance testing including electrical safety, EMC, software validation, and human factors studies.