South Korean medical device company Wontech said Tuesday it has received regulatory approval in Indonesia for its Holinwon Pro holmium laser surgical system, marking a significant step in the company’s expansion into Southeast Asia’s growing surgical device market.
Indonesia’s Ministry of Health approved Holinwon Pro for a range of surgical applications, including ureteroscopic stone removal procedures, prostate surgery and endoscopic spine surgery, after determining that the device met safety and efficacy requirements.
Holinwon Pro is a surgical platform that utilizes a 2,100-nanometer holmium laser. The system incorporates a proprietary optical fiber measuring less than 1 millimeter in diameter, enabling minimally invasive endoscopic procedures while minimizing damage to surrounding tissue through precise energy delivery.
The approval represents Wontech’s second surgical-device clearance in Indonesia. The company previously secured approval for its Holinwon Prima system and has continued expanding its surgical product portfolio in the country.
Indonesia, home to roughly 280 million people and Southeast Asia’s largest economy, has emerged as a key growth market for medical technology companies as healthcare infrastructure expands and national health insurance coverage broadens.
According to the U.S. International Trade Administration, Indonesia’s medical device market is projected to reach approximately $2.8 billion in 2025.
Reflecting growing demand, Wontech said it had already secured a supply agreement for Holinwon Pro prior to receiving regulatory approval through its existing local partnership network. The company plans to accelerate commercial activities following the clearance.
Later this month, Wontech is scheduled to conduct product demonstrations at four major university hospitals in Indonesia. The demonstrations will allow local physicians to evaluate the system’s clinical performance and surgical applications in real-world settings while helping the company build clinical references and support future sales efforts.
“The fact that we received purchase commitments before obtaining regulatory approval demonstrates the level of confidence local partners have in the technology,” a Wontech official said. “Following our success in aesthetic devices, we intend to establish surgical systems as another core growth pillar and actively expand our surgical business across Indonesia and the broader Southeast Asian market.”
Wontech reported first-quarter revenue of approximately $27 million and operating profit of about $10.5 million, both quarterly records for the company. Overseas markets accounted for roughly 70% of total revenue, highlighting Wontech’s export-driven business model as it continues to expand in emerging markets including Thailand and Brazil.