QTO · Digital Visual Acuity Test
Ophthalmic · 21 CFR 886.1150 · Class 1
Overview
| Product Code | QTO |
|---|---|
| Device Name | Digital Visual Acuity Test |
| Regulation | 21 CFR 886.1150 |
| Device Class | Class 1 |
| Review Panel | Ophthalmic |
Identification
A visual acuity chart is a device that is a chart, such as a Snellen chart with block letters or other symbols in graduated sizes, intended to test visual acuity.
Classification Rationale
Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 886.9. The device is also exempt from the current good manufacturing practice requirements of the quality management system regulation in part 820 of this chapter, except for requirements concerning records and complaint files under § 820.35 of this chapter.
Recent Cleared Devices (1 of 1)
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K220090 | Visibly Digital Acuity Product | Visibly, Inc. | Aug 12, 2022 | SESE |
Top Applicants
- Visibly, Inc. — 1 clearance
