K220090 is an FDA 510(k) clearance for the Visibly Digital Acuity Product. This device is classified as a Digital Visual Acuity Test (Class I - General Controls, product code QTO).
Submitted by Visibly, Inc. (Chicago, US). The FDA issued a Cleared decision on August 12, 2022, 213 days after receiving the submission on January 11, 2022.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1150. A Digital Visual Acuity Testing System Is Intended As An Aid In The Assessment Of Visual Acuity In Patients..
| 510(k) Number | K220090 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | January 11, 2022 |
| Decision Date | August 12, 2022 |
| Days to Decision | 213 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | QTO - Digital Visual Acuity Test |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.1150 |
| Definition | A Digital Visual Acuity Testing System Is Intended As An Aid In The Assessment Of Visual Acuity In Patients. |