FDA-Cleared Next-Generation Monopolar RF Device Delivers Comfort and Results

Monopolar radiofrequency (RF) has been a major modality in aesthetics for more than two decades. Given its reputation as a safe and effective, non-invasive therapy, it remains relevant today.

Volnewmer from Classys (Seoul, Korea) received FDA clearance in April 2024 and features a high-frequency current of 6.78 MHz, to safely penetrate to the deeper dermis and generate heat that induces the therapeutic thermal effect. It is designed to maximize patient comfort with a combination vibration and water-cooling system, so no anesthesia is needed. “With the increase in average life expectancy comes a natural increase in [patient] demand for measures to maintain health and a youthful appearance,” explained Yousun Hwang, MD, of the Haedrin Clinic, Center for Aesthetic Medicine (Seoul, Korea). “Although cosmetic surgeries remain popular, many seek natural and less invasive procedures to restore their youthful appearance. Treatment with Volnewmer has almost no downtime, and in my practice, no noticeable side effects have been experienced by my patients,” she noted. “With this benefit, in addition to gradual skin tightening, patients eagerly return to my office for maintenance treatments.”

Dr. Hwang is lead author on a recently published study¹ (n=50) that examined patient experience and satisfaction with a single session of full-face treatment using Volnewmer monopolar RF without anesthesia. The goal was to gather data for future tuning of treatment parameters. Approximately 82% of patients reported satisfaction with treatment, including significant improvement in skin laxity (52.9%), skin texture (17.6%) and skin tone (11.7%). Peak effect was noted between one- and two-months post-treatment. Side effects included erythema and swelling, which resolved within one week. “With high satisfaction and improvement in skin tightening, skin tone and texture, coupled with minimal downtime and tolerable pain reported by patients, I believe that Volnewmer will become the new leader in the flourishing RF market,” stated Dr. Hwang.

A Closer Look at Comfort

Continuous epidermal cooling includes four-step vibration so that patients have a quick and comfortable treatment experience. Volnewmer also features a selection of four treatment tips to accommodate various anatomical locations on the face and body: the V Tip (4.0 cm2), I Tip (0.25 cm2), S Tip (16.0 cm2) and F Tip (3.0 cm2), each of which has a curved surface and rounded tip head. Treatment tips are somewhat flexible at the head to accommodate movement more easily across the skin during treatment. “Compared to previous monopolar RF devices, the Volnewmer cartridge has no time-lock system, meaning that the user physician does not feel pressured to treat a certain number of patients within a limited time frame,” explained Dr. Hwang. “This is a huge advantage for the physicians who do not want to waste the cartridges, making this treatment incredibly cost-effective and easy to perform. “Ideal candidates for treatment would be patients with mild to moderate skin laxity, but in my opinion anyone with skin laxity can benefit from Volnewmer treatment,” Dr. Hwang commented. “Even those with more severe skin laxity could benefit from Volnewmer treatment, not just in skin tightening but also in the overall rejuvenation of the face.”

Reference:

1. Hwang Y, Arayaskul S, Vachiramon V, Yi KH. Subjective evaluation of monopolar radiofrequency treatment by patients in aesthetic rejuvenation. Skin Res Technol. 2024;30(2):e13593. doi:10.1111/srt.13593