FDA Classifies Ophthalmic Device as Class II
The FDA is classifying the strabismus detection device as class II.
After review of the information submitted in the request, FDA determined that the device can be classified as class II with the establishment of special controls.
This order is effective September 22, 2016.
View the ruling here: www.fdanews.com/09-22-16-OpthalmicDevicesClassII.pdf. — Cynthia Jessup