DeviceClearance

Product code QTO— Ophthalmic

Visibly Digital Acuity Product

Classification name
Digital Visual Acuity Test
Device class
Class 1
Regulation
21 CFR 886.1150
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

“A Digital visual acuity testing system is intended as an aid in the assessment of visual acuity in patients.”

— U.S. Food and Drug Administration, device classification record for product code QTO under 21 CFR 886.1150, via openFDA

Market context for product code QTO

FDA has cleared 1 device under product code QTO, all in 2022, filed by 1 applicant company. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Top applicants under product code QTO

Recent clearances under product code QTO

Data sourced from openFDA. This site is unofficial and independent of the FDA.