Device product
The Visibly Online Refractive Vision Test which is part of the Visibly Vision Test Solution, This is a software application that partners and their customers were given access to. Product Usage: This online portion of the Visibly Vision Test Solution is used to measure vision refraction.
Z-2223-2019
Product summary
- Firm
- Opternative Inc
- Event
- Event 83298
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 32
- Official record key
device-enforcement:Z-2223-2019
Official wording
Reason: Lack of 510K clearance
Code information: ALL
Distribution pattern: Worldwide distribution. US Nationwide distribution in the states of AZ, CA, DE, FL, IL, MO, NV, NY, OH, PA, TX, WA, and UT. Country of Canada.
Derived failure modes
-
Unknown
Lack of 510K clearance