DeviceClearance

Product code NXR— Ophthalmic

EYEPORT VISION TRAINING SYSTEM

Classification name
Fixation, Vision Training, Binocular
Device class
Class 1
Regulation
21 CFR 886.1290
Advisory panel
Ophthalmic
Total cleared
1
First cleared
Most recent

FDA classification definition

“To improve speed, accuracy, and coordination of binocular eye movements and changes of accommodation. To treat poor accommodation and vergence facility, convergence insufficiency, and accommodative lag.”

— U.S. Food and Drug Administration, device classification record for product code NXR under 21 CFR 886.1290, via openFDA

Market context for product code NXR

FDA has cleared 1 device under product code NXR, all in 2006, 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 NXR

Recent clearances under product code NXR

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