Evaluation of a Multipolar MEMS Based Low‐Power Radiofrequency Device for Pain‐Free Facial Rejuvenation: A Prospective Clinical Study
4 affiliations
- 1Department of Electrical Engineering and Computer Science University of California, Irvine Irvine California USA
- 2Zhejiang‐California International NanoSystems Institute Hangzhou China
- 3Department of Dermatology University of California, Irvine Irvine California USA
- 4DSC Laser & Skin Care Center San Gabriel California USA
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.
Related
- Microfocused ultrasound for facial and neck rejuvenation : A pilot prospective observational study on efficacy and safety in patients with skin laxity
- inClinico Agent for clinical trial endpoint prediction and prospective evaluation
- Pulmonary Vein Isolation with Different Single-Shot Ablation Devices in Patients with Atrial Fibrillation: A Prospective Observational Single-Center Clinical Evaluation
- Evaluation of the Efficacy and Safety of Combination Therapy of Vamha and Myrha in the Management of PMOS: An Open-Label, Randomized, Multicentre, Comparative, Prospective Clinical Study
- Real-time Evaluation and Anticipation of Causal disTillation early prediction for cardiac surgery-associated acute kidney injury (REACT-01): study protocol for a single-center prospective randomized clinical trial
BibTeX
@article{mao2026evaluation,
title = {{Evaluation of a Multipolar MEMS Based Low‐Power Radiofrequency Device for Pain‐Free Facial Rejuvenation: A Prospective Clinical Study}},
author = {Rongwei Mao and Shengshuo Yan and Aditi A. Sharma and Tony Shum and Yang Zhang},
journal = {Journal of cosmetic dermatology},
year = {2026},
month = oct,
doi = {10.1111/jocd.71258},
url = {https://europepmc.org/article/PMC/PMC13717053},
note = {CC BY},
}
RIS
TY - JOUR
TI - Evaluation of a Multipolar MEMS Based Low‐Power Radiofrequency Device for Pain‐Free Facial Rejuvenation: A Prospective Clinical Study
AU - Rongwei Mao
AU - Shengshuo Yan
AU - Aditi A. Sharma
AU - Tony Shum
AU - Yang Zhang
PY - 2026
DA - 2026/10/28
JO - Journal of cosmetic dermatology
DO - 10.1111/jocd.71258
UR - https://europepmc.org/article/PMC/PMC13717053
AB - 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.
SN - 1473-2130
SN - 1473-2165
ER -