OPTI Medical Systems

About

OPTI Medical Systems develops, manufactures, and markets ophthalmic surgical instruments and devices used in cataract and glaucoma procedures. The company focuses on single-use and disposable products for improved safety and efficiency. OPTI Medical Systems is headquartered in Irvine, California, USA.

As a manufacturer of ophthalmic medical devices in the United States, OPTI Medical Systems is regulated by the FDA under 21 CFR Part 820 and requires 510(k) clearance or Premarket Approval (PMA) for their products. They are likely a member of AdvaMed.