Notable News

10/07/2024: VIS, Inc. Receive its Medical Device Single Audit Program (MDSAP) Certification. The MDSAP is an international initiative based on the quality management system standards outlined in ISO 13485 that allows a single regulatory audit of a medical device manufacturer’s quality management system to satisfy the requirements of multiple regulatory authorities. For more information please visit: https://www.fda.gov/medical-devices/cdrh-international-affairs/medical-device-single-audit-program-mdsap.

10/04/2024: VIS, Inc. received its ISO 13485:2016 Certification. This means that VIS, Inc. has implemented and maintains a Quality Management System for Medical Devices. The certificate covers the following activities: Design and development, manufacturing, distribution, installation and servicing of active systems for eye care procedures.

09/23/2024: The Ethics Review Board for VIS, Inc. and Opti-K™, approves the Health Canada Investigational Testing Authorization (ITA) for the Treatment of Presbyopia. Principal Investigator training is scheduled for 09/26/24. Patient screening and treatments for presbyopia are scheduled for October Q4 2024.

08/26/2024: Health Canada Approves the Opti-K™ Investigational Testing Authorization (ITA) For the Treatment of Presbyopia.

08/09/2024: Based on the approved Investigational Testing Authorization (ITA) for Age-Related Macular Degeneration (AMD), VIS, Inc. installs and calibrates the Opti-K™ system at our Toronto clinical site and Chief Medical Officer Harry Glen MD trains the Principal Investigator on the Opti-K™ procedure. Patient screening and treatments for AMD are scheduled for October Q4 2024.

07/02/2024: VIS, Inc. receives a structured equity investment to finance US and Canadian operations including clinical site initiation, regulatory efforts, and system manufacturing.

05/03/2024: VIS, Inc. launches patient screening for the Opti-K™ Phase IIIa Pivotal Study.

05/01/2024: VIS, Inc. releases a Private Placement Memorandum (PPM) Class D Preferred Convertible for Accredited investors.

04/17/2024: VIS LLC, a Texas Limited Liability Company, converts to VIS, Inc., a Texas C-Corporation.

01/01/2024: The Opti-K™ procedure is the Cover Story for Cataract & Refractive Surgery Today (CRST) A New Approach to Thermal Keratoplasty.

12/20/2023: Health Canada Approves The Opti-K™ Investigational Testing Authorization (ITA) for the Treatment of Age-Related Macular Degeneration (AMD).

04/19/23: FDA Approves The Opti-K™ Investigational Device Exemption (IDE) for the Phase III FDA Pivotal Study for the Treatment of Presbyopia.

VIS understands that sight is very precious; the one sense people fear losing most. VIS’ mission is to commercialize and scale proprietary, laser-based optical device systems for ophthalmologists to treat patients using, safe, fast, and affordable procedures with excellent results.

DISCLAIMER: The VIS Optimal Keratoplasty (Opti-K™) System is an investigational device, and it is not available for sale or use in the United States.

VIS, Inc.
2800 Dallas Parkway, Suite 100
Plano, TX 75093
United States of America
Monday - Friday 8:00 AM - 6:00 PM
[email protected]
+1 561 819 8300