Digital Visual Acuity Test
The Digital Visual Acuity Test is a digital system intended as an aid in the assessment of visual acuity in patients, providing an electronic or software-based alternative to traditional printed eye charts for measuring how well a patient can resolve fine detail. It is used in ophthalmologic and optometric clinical settings. Classified as FDA Class 1 under regulation 886.1150, it is subject to general controls only and is 510(k) exempt in the Ophthalmic specialty. It is not an implant and not life-sustaining.
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Basic Information
- Product Code
- QTO
- Device Class
- FDA class 1
- Regulation Number
- 886.1150
- Medical Specialty
- Ophthalmic
- Review Panel
- OP
- Submission Type
- 4
Device Characteristics
Definition
A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients.
510(k) Clearance History
Related 510(k) Clearances
This FDA classification is associated with 1 510(k) clearance via K numbers.
| K Number | Device Name | Decision Date | Decision | Applicant |
|---|---|---|---|---|
| K220090 | Visibly Digital Acuity Product | Aug 12, 2022 | Substantially Equivalent | Visibly, Inc. |
FEI Numbers
This FDA classification entry is associated with 31 FEI numbers. Click on an entry to view related FDA registrations.
Registration Numbers
This FDA classification entry is associated with 31 registration numbers. Click on an entry to view related FDA registrations.