QTO — Digital Visual Acuity Test Class I
FDA product code QTO covers "Digital Visual Acuity Test", a Class I medical device regulated under 21 CFR 886.1150. Submissions are reviewed by the Ophthalmic panel. At least 1 recent 510(k) clearance has been granted under this product code.
Classification Details
- Product Code
- QTO
- Device Class
- Class I
- Regulation Number
- 886.1150
- Submission Type
- Review Panel
- OP
- Medical Specialty
- Ophthalmic
- Implant
- No
Definition
A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients.
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K220090 | visibly | Visibly Digital Acuity Product | August 12, 2022 |