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ViOL Receives FDA Approval for New Monopolar RF Device 'Cellinew'

Global skincare medical device company ViOL announced on the 27th that its new monopolar RF device, Cellinew, has received approval from the U.S. Food and Drug Administration (FDA).

Following the approval by Korea's Ministry of Food and Drug Safety (MFDS) in March 2024, Cellinew has now gained international recognition for its safety and effectiveness with FDA approval. In 2020, ViOL received FDA approval for its Sylfirm X, a microneedle RF device. With the new Cellinew, the company has again demonstrated its global technological capabilities and expertise in international certifications.

Cellinew uses 6.78 MHz monopolar radiofrequency to deliver heat to the dermal layer of the skin non-invasively. This induces collagen remodeling and tightening, which helps improve skin elasticity. Notably, the device allows 600 shots in just over 13 minutes, garnering significant attention from medical professionals worldwide. This is made possible by the Repetition Mode, which ensures stable and effective treatments, and the Auto Fit function, which automatically adjusts output according to the skin characteristics of the treated area.

Cellinew has received positive doctors' feedback for its short treatment time and exceptional results. With the recent FDA approval, the device is expected to accelerate ViOL’s entry into the U.S. market. ViOL’s CEO, Sang-jin Lee, stated,

“We plan to quickly find a local distribution partner in the U.S. and accelerate our market penetration. We will also work to promote Cellinew's excellence in global markets.”