# K220090: Visibly Digital Acuity Product

- Pathway: 510(k) (Traditional)
- Applicant: Visibly, Inc.
- Decided: Aug 12, 2022 after 213 days
- Product code: QTO (Digital Visual Acuity Test)
- Device class: 1
- Regulation: 21 CFR 886.1150
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K100095 (2010). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K100095: Central Vision Analyzer Model 1000, Vimetrics,Llc. (2010) Summary page 6.

## Indications for use
The Visibly Digital Acuity Product (VDAP) is a web-based, self-guided software application intended for use by adults, ages 22 to 40, who have the capability to perform a self-test at home, to aid in the evaluation of visual acuity with or without correction. The software allows users to view and respond to displayed optotypes and uses the responses to categorize a patient’s visual acuity into one of two categories, with an individual output for each eye: e TRUE - visual acuity that is consistent with normal vision e FALSE - visual acuity that is not consistent with normal vision The Visibly Digital Acuity Product recommendations are intended to be supportive recommendations that will be used by an eye care provider, along with the patient’s medical history and profile, prior corrective eyewear prescriptions, and subjective vision data. The Visibly Digital Acuity Product does not provide screening or diagnosis of eye health or other disease, nor is it intended to replace an in-person eye exam.

Source page: https://510kreport.com/device/K220090
Methodology: https://510kreport.com/methodology