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Alaska, California, Delaware, District of Columbia (DC), Idaho, Kansas, Louisiana, Maine, Michigan, New Jersey, New Mexico, Oklahoma, Puerto Rico, South Carolina, Vermont, West Virginia.
This version of the Visibly Digital Acuity Product and the Single Device Acuity Product are manufactured and distributed by Visibly, Inc. and operate under the Enforcement Policy for Remote Ophthalmic Assessment and Monitoring Devices during the Coronavirus Disease (COVID-19) Public Health Emergency issued by the FDA in April 2020. Neither product has been approved by the FDA. A different version of the Visibly Digital Acuity Product received 510(k) clearance from the FDA, but that is not the version of the product made available here. The data and recommendations made by the Visibly Digital Acuity Product and Single Device Acuity Product are adjunctive (supporting) recommendations that will be used by an Eye Care Provider, along with your medical history and profile, prior corrective eyewear prescriptions, and subjective data provided about your vision. It is the responsibility of the patient to provide accurate information through the process as all of this information will be relied upon as accurate by the reviewing Eye Care Provider. All Eye Care Providers are associated with Optimized Eyecare, P.C., or other entities that provide clinical services. Visibly, Inc. is an independent entity that does not provide any eyecare or clinical services.
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