We are proud to announce that LI Medical Corporation has successfully received U.S. FDA 510(k) clearance (K031463) for our complete family of medical-grade pessaries. This important regulatory milestone affirms the safety and effectiveness of our pessary products and enables us to confidently supply the U.S. market with a comprehensive range of solutions for pelvic organ prolapse (POP) and urinary incontinence management.

With this clearance, LI Medical joins a select group of manufacturers recognized by the FDA for meeting the stringent requirements for Class II medical devices in gynecology. Our pessaries are designed with patient comfort, ease of use, and clinical performance in mind, and are available in a wide variety of shapes and sizes to suit diverse anatomical needs and physician preferences.

Backed by ISO 13485 certified manufacturing and nearly a decade of experience producing for some of the most respected brands in women’s health, LI Medical is committed to supporting healthcare professionals with reliable, high-quality products that improve patients’ quality of life.

This achievement reflects our dedication to regulatory excellence, product innovation, and continued growth in the global medical device market.