Visibly Gets 510(k) Clearance for Its Online Eye Test

Chicago, Ill.-based Visibly has received 510(k) clearance from the FDA for its Visibly Digital Acuity Product (VDAP), making it the first FDA-cleared online visual acuity test on the market.

The on-demand and self-administered test uses a combination of a touchscreen mobile device and a computer connected to the internet.

The test takes six minutes to complete and the results are made available to eye care professionals to help them determine the best course of action for each patient.

The clearance was supported by study results that demonstrated the online test’s efficacy and safety, the company said.