On the 20th, global medical aesthetic specialist CLASSYS announced that it has obtained European CE Medical Device Regulation (MDR) certification for its monopolar radiofrequency (MRF) device, Volnuma.
Volnuma is a non-invasive monopolar radiofrequency (RF) device that uses 6.78 MHz to promote collagen generation in the skin, improving skin elasticity and volume.
The CE MDR is a medical device regulation that must be complied with to export to the European market, which strengthens the previous directive, MDD (Medical Device Directive), and has been implemented since May 2021.
The company explained that CLASSYS's Volnuma is the first RF aesthetic medical device to gain CE MDR certification for its effectiveness and safety. Previously, the company published 19 papers based on monopolar RF technology and demonstrated the product's safety and efficacy by publishing them in SCIE-level international journals. Additionally, it has strengthened its licensing organization by recruiting specialized personnel in the European aesthetic medical device sector.
CLASSYS plans to make its full-scale entry into the European market based on this certification. The company intends to proactively start sales in the European market ahead of competitor products. It is also preparing to hold a Volnuma launch symposium in major countries such as Poland and Switzerland starting in June. The company noted its plans to actively promote marketing targeting local partners and medical professionals through the 'CLASSYS Academy' training program, in conjunction with the Ultraformer MPT (domestically known as Shurink Universe), which is expected to obtain CE MDR certification in July.
A CLASSYS representative said, 'We will actively expand Volnuma sales and accelerate global growth with our first entry into the U.S. in 2024 and a full-scale entry into Europe in 2025.'