DeviceClearance

Product code QTW— Ophthalmic

EyeCTester

Classification name
Digital Amsler Grid
Device class
Class 1
Regulation
21 CFR 886.1330
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

“A Digital Amsler grid is intended as an aid in detection of central visual irregularities caused by changes in the visual pathway in patients.”

— U.S. Food and Drug Administration, device classification record for product code QTW under 21 CFR 886.1330, via openFDA

Market context for product code QTW

FDA has cleared 1 device under product code QTW, 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 QTW

Recent clearances under product code QTW

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