Patents
Myopia Control Device patent application – Patent # 20260191685
System and method for defining and controlling LTK and other surgical eye procedures to produce little or no stromal collagen shrinkage – Patent # 8603081
Deuterated ocular solutions for LTK and other surgical eye procedures – Patent # 7691099
Trademarks
Opti-K Trademark – Registration # 3779736
Regulatory
In the United States of America, Opti-K® is currently in the FDA Premarket Approval (PMA) Phase III Pivotal Study—the final phase of our FDA clinical trial program.
In Canada, VIS holds an approved Medical Device License (MDL) for Opti-K® issued by Health Canada. The procedure is authorized as a fee-for-service offering.
Quality Management & Global Compliance
VIS is certified to ISO 13485:2016, the international standard for medical device quality management systems. This certification authorizes us to manufacture, distribute, and service our own device.
VIS also participates in the Medical Device Single Audit Program (MDSAP). Under MDSAP, a single audit of our quality system by an accredited third-party organization satisfies the regulatory requirements of multiple participating countries, improving efficiency and reducing compliance costs.
