FDA Product Code SBI: Manual Refractor, 3d Display
A 3d Display Manual Refractor Is An Optical Device Intended To Measure The Refractive Error Of The Eye.
Leading manufacturers include Evolution Optiks Limited.
1
Total
1
Cleared
245d
Avg days
2024
Since
Declining activity -
0 submissions in the last 2 years
vs 1 in the prior period
FDA 510(k) Cleared Manual Refractor, 3d Display Devices (Product Code SBI)
1 devices
About Product Code SBI - Regulatory Context
510(k) Submission Activity
1 total 510(k) submissions under product code SBI since 2024, 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.