Pure Global AI
FDA product code QTW

Digital Amsler Grid

OphthalmicClass 121 CFR 886.1330
Verified
US regulatory classifications
US Product Code (FDA)
QTW
View Product Code Classification
US Risk Class (FDA)
Class 1
US Regulation (CFR)
21 CFR 886.1330
View CFR Regulation
Medical specialty
Ophthalmic
Device characteristics
GMP exempt
No
Implantable
No
Life-sustaining
No
Third party review
Not Eligible
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.

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About this record

Digital Amsler Grid is a medical device type in the Ophthalmic specialty. This page includes real-world medical device registration data worldwide for this device type, with registrations from US FDA, Brazil ANVISA, and other global markets.

View regulatory classifications, recent 510(k) clearances, active device registrations, and similar products registered globally under this device category. Pure Global AI's free directory provides comprehensive worldwide registration intelligence across 7,000+ medical device types and 21 specialties.