FDA Product Code QWU: Prosthesis, Eyelid Spacer/graft, Polymer
For Implantation To Reinforce And Aid In Reconstruction Of The Soft Tissues Of The Eyelid And Eyelid Area.
Leading manufacturers include Corneat Vision , Ltd..
1
Total
1
Cleared
245d
Avg days
2023
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Prosthesis, Eyelid Spacer/graft, Polymer Devices (Product Code QWU)
1 devices
About Product Code QWU - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code QWU since 2023, with 1 receiving FDA clearance (average review time: 245 days).
Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.
QWU devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →