ViOL’s ‘Cellinew Gains Medical Device Approval in Indonesia and

Sylfirm X Receives Indication Approval for Melasma and Wrinkles in Taiwan

TViOL, a global leader in medical aesthetic devices, is ramping up its efforts to capture the Asian market. The company recently announced that its monopolar RF lifting device, Cellinew, has received medical device approval in Indonesia. In contrast, its microneedling RF device, Sylfirm X, has been granted indication approval by the Taiwan Food and Drug Administration (TFDA) for treating melasma, fine wrinkles, acne, and acne scars.

With the Indonesian approval of Cellinew, ViOL has officially entered a massive market with a population of approximately 280 million. The company also plans to use this as a strategic foothold to expand into neighboring countries such as Malaysia, Vietnam, and the Philippines. Indonesia is considered an emerging medical aesthetic market with high growth potential, and ViOL expects it to play a pivotal role in its expansion across Southeast Asia.

Meanwhile, the indication approval for Sylfirm X in Taiwan represents a clinically recognized achievement in treating pigmentation disorders and skin aging. This approval will significantly boost trust and credibility among Taiwan’s medical aesthetic community and consumers. Known for its short downtime and quick recovery and having been recognized as a patented original technology by the International Trade Commission (ITC), Sylfirm X stands out with its technological superiority.

ViOL holds medical device approvals in over 20 countries worldwide, including the U.S. FDA, European CE-MDR, and Korea’s MFDS, and continues expanding its global certification portfolio. With the recent approvals in Indonesia and Taiwan, the company strengthens its momentum across the Asian market and aims to expand its global footprint into the Middle East and Europe.

A ViOL representative stated, “These approvals mark an important turning point in our strategy for the Asian market. Building on the strengths of K-beauty technology, we will continue to expand beyond Southeast Asia into the Middle East and Europe, solidifying our position as a global leader.”