Evaluation of a Multipolar MEMS Based Low‐Power Radiofrequency Device for Pain‐Free Facial Rejuvenation: A Prospective Clinical Study

ABSTRACT Background Noninvasive radiofrequency (RF) therapy has emerged as a prominent approach for facial rejuvenation due to its ability to stimulate collagen remodeling without epidermal ablation. However, conventional RF systems often rely on high thermal output, posing risks of heat‐induced dermal damage. Objective This study aimed to evaluate the safety and efficacy of a novel micro‐RF device (nebulyft), utilizing a high‐density 321‐electrode MEMS array designed to deliver high precision low‐power phase‐controlled RF energy for facial wrinkle reduction and improved skin texture. Methods In this prospective, open‐label clinical trial, 42 participants from California, USA (age 29–62, Fitzpatrick skin types II–IV) completed a 4‐week treatment protocol using the nebulyft device. Each subject underwent one supervised clinic‐based session, followed by at‐home treatments (16 min per session, ≥ 5 sessions per week). Efficacy was assessed using the Fitzpatrick Wrinkle Severity Scale (FWSS) by three blinded board‐certified dermatologists, and subject satisfaction was recorded via a 4‐point Likert scale. Results At one‐month post‐treatment visit, 90.5% of participants in the primary FAS (38/42) met the ≥ 1‐point FWSS responder criterion; the supportive PPS result was 92.7% (38/41), as determined by at least two blinded evaluators (FAS exact one‐sided p = 0.0015 vs. the prespecified 70% performance goal). The mean subject satisfaction score was 15.76 ± 0.54 out of 16. No pain was reported by any participant during treatment sessions. No adverse events, discomfort, or device malfunctions were reported.