Singapore and Shenzhen, China, 30 June 2025 – WIKKON®, China’s market leader in urology and shock wave therapy devices, today announced U.S. FDA 510(k) clearance for its U200 Extracorporeal Shock Wave Lithotripter. This marks a key turning point for the company and reinforces its readiness to expand globally, as FDA clearance is widely recognized as a benchmark for regulatory and clinical excellence in many international markets.
The FDA clearance reflects WIKKON®’s ongoing commitment to making advanced, non-invasive urology solutions accessible to more patients worldwide. WIKKON® is a subsidiary of Advanced MedTech Holdings, a global medical technology leader in urology.
The WIKKON® U200 is an advanced extracorporeal shock wave lithotripter that combines effective, non-invasive kidney stone treatment with an integrated ultrasound stone localization system, eliminating radiation exposure and the need for lead shielding. Its standout features include a 2-step positioning system with Assisted Movement for rapid and precise stone targeting, a flexible therapy head with 300 mm vertical motion, and a pivotable main unit that allows for easier patient repositioning. With electromagnetic shock wave technology delivering consistent energy and wide-angle treatment access, the U200 is a significant advancement in urological care[ The WIKKON® U200 is FDA-cleared in the U.S. for specific indications for use. Availability, approved indications for use, and labelling outside the U.S. may vary and are subject to local regulatory approvals in each respective market. 1
Mr. Alex Wu, General Manager for Dornier Asia North & WIKKON®, said “Securing this milestone underscores our unwavering commitment to advancing urological care and expanding access for patients worldwide. The U200’s regulatory approval marks just the beginning—we’re doubling down on innovation and strategic partnerships to bring world-class solutions beyond China and into more hands globally.”
Mr. Wong Yau Chung, Group CEO, Advanced MedTech, said, “WIKKON®’s regulatory success with the U200 is a powerful testament to what we can achieve through true global collaboration. Dornier, WIKKON® and teams across Advanced MedTech came together with focus, expertise, and a shared vision—demonstrating the strength and synergy of our global network. This is more than a milestone; it’s a launchpad for even greater impact ahead.”
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About WIKKON
WIKKON® (Shenzhen WIKKON Precision Instruments Co., Ltd.) is a High and New Technology Enterprise with medical device research, engineering and manufacturing capabilities, based in Shenzhen, China. Founded in 1996, WIKKON is dedicated to innovation in the field of Extracorporeal Shock Wave Lithotripsy (ESWL) for kidney stone removal, Extracorporeal Shock Wave Therapy (ESWT) for erectile dysfunction and joint pain relief and Urology Imaging Table for all-purpose of medical exams and procedures. For more information, visit https://eswl.com.
About Dornier MedTech
Dornier MedTech is a medical device company near Munich, Germany, and is a wholly owned subsidiary of Advanced MedTech Holdings. As pioneers of the shock wave lithotripsy method and a leader in urological care, Dornier is one of the most trusted names in the industry. Through its deep-rooted spirit of entrepreneurship and excellence, Dornier continues to spearhead innovation in urology, developing some of the highest quality urological devices on the market today. Given its vast array of clients, Dornier is leading technology and improving life across the globe. For more information, visit https://www.dornier.com.
About Advanced MedTech Holdings
Advanced MedTech Holdings is a global medical technology leader with a core focus in urology devices and contract manufacturing services. The Group serves millions of patients and physicians in 100 countries worldwide. Advanced MedTech Holdings makes strategic investments in disruptive medical technology companies, strengthening its portfolio of healthcare solutions for customers around the world. Advanced MedTech Holdings is a wholly owned subsidiary of Temasek. For more information, visit https://www.advanced-medtech.com.
1The WIKKON® U200 is FDA-cleared in the U.S. for specific indications for use. Availability, approved indications for use, and labelling outside the U.S. may vary and are subject to local regulatory approvals in each respective market.