By Fineline Cube 
Acotec Scientific Holdings Limited (HKG: 6669) announced on October 7, 2025 that its Endovenous Radiofrequency Ablation System has secured a 510(k) clearance from the U.S. Food and Drug Administration (FDA). The clearance validates the system’s safety and effectiveness for treating lower‑extremity varicose veins caused by superficial venous reflux.
System Overview
- Components – The system integrates the Cedar Endovenous Radiofrequency Catheters with an Endovenous Radiofrequency Generator.
- Clinical Application – Designed for minimally invasive ablation of varicose veins, providing patients with a shorter recovery time and reduced post‑procedural pain.
Regulatory & Commercial Milestones
- FDA 510(k) Approval – The clearance confirms that the device meets the FDA’s “substantial equivalence” standard, allowing it to be marketed in the United States.
- Distribution Agreement – Acotec Scientific has entered a partnership with a member of the BSC Group to distribute the product in the U.S. market.
- Commercial Roll‑out – The BSC Group will commence U.S. commercialization once regulatory and supply‑chain preparations are complete.
Strategic Implications
- Market Expansion – The FDA clearance opens a significant U.S. market for Acotec’s vascular therapy portfolio, complementing its existing product lines in China and other regions.
- Revenue Growth – Early U.S. commercial deployment is expected to accelerate revenue streams and enhance the company’s valuation among healthcare investors.
- Innovation Credibility – Achieving 510(k) status reinforces Acotec’s position as a leader in endovenous technology, potentially attracting further partnerships and investment.-Fineline Info & Tech