Dermatrix Duo

The Dermatrix Duo is a radiofrequency system for dermatologic procedures with two handpieces: a Microneedle RF (MFR) handpiece with 16 or 49 needle cartridges for microneedling, and a Superficial RF (SFR) handpiece with 64 non-invasive electrodes. The device is intended for electrocoagulation and hemostasis, and the SFR applicator is indicated for relief of minor muscle aches, pain, muscle spasm, and temporary improvement of local blood circulation.

The subject device operates at 1 MHz bipolar frequency with maximum power of 50W, compared to predicates that support 1–2 MHz and higher power. The microneedle diameter is 0.2 mm (smaller than predicate's 0.3 mm); needle configurations differ (16 and 49 needles vs. predicate's 36 and 1). The SFR applicator has an electrode area of 441 mm² and RF duration of 10–400 ms, whereas the predicate offers up to 614.7 mm² and up to 30 seconds duration.

IEC 60601-1 Edition 3.2, IEC 60601-1-2:2014, IEC TS 60601-4-2 Edition 1.0, IEC 60601-2-2:2017, ISO 10993-1, IEC 62304:2006+A1:2015, and EN ISO 14971:2012. Biocompatibility testing included cytotoxicity, sensitization, irritation, systemic toxicity, and pyrogen testing. Ex-vivo histology testing and tissue heating testing were performed per FDA guidance.

The Dermatrix Duo is substantially equivalent because it has the same indications for use, technology (radiofrequency), mechanism of action (thermal coagulation), and operational principles as the Virtue RF and EndyMed MiniShaper Max predicates. Although there are differences in frequency, power, needle configuration, and electrode area, performance testing (histology and tissue heating) demonstrated that the subject device creates similar thermal damage patterns and maintains therapeutic temperatures equivalent to the predicates, establishing that these differences do not raise different safety or effectiveness questions.