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OCULOGICA

FDA Regulatory Profile

Summary

Total Recalls
1
510(k) Clearances
5
Inspections
0
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2398-2019Class IIEyeBOX Model OCL 02April 16, 2019

Recent 510(k) Clearances

K-NumberDeviceDate
K242116EyeBOX EBX-4.1April 4, 2025
K212310EyeBOX (Model EBX-4)December 22, 2021
K201841EyeBOXSeptember 6, 2020
K191183EyeBOXJuly 31, 2019
DEN170091EyeBOXDecember 28, 2018