QQUClass II
Digital Therapy Device For Amblyopia
Ophthalmic · 21 CFR 886.5500
A digital therapy device for amblyopia is a device that incorporates dichoptic presentations on visual displays through therapeutic algorithms to treat amblyopia or to improve visual acuity of patients with amblyopia.
MDR events1All time
Recalls0All time
Registered firms2Currently listed
510(k) clearances5All time
Recent MDR events
1 adverse event reports on file
Event type breakdown
Injury1
Most-reported manufacturers
Recalls
0 recall events for this product code
No recalls on file for this product code.
Registered firms
2 firms currently registered for this product code
510(k) clearances
5 clearances for this product code