510(k) K220090
K220090 is an FDA 510(k) premarket notification submitted by Visibly, Inc. for the device "Visibly Digital Acuity Product". The FDA issued a decision of Substantially Equivalent on August 12, 2022. The device falls under product code QTO (Digital Visual Acuity Test), a Class I device regulated under 21 CFR 886.1150.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 2022
- Date Received
- January 11, 2022
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Digital Visual Acuity Test
- Device Class
- Class I
- Regulation Number
- 886.1150
- Review Panel
- OP
- Submission Type
A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients.