OCULOGICA

FDA Regulatory Profile

OCULOGICA appears in FDA public data with 1 recall, 6 510(k) clearances, 0 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2398-2019, Class II) was initiated on April 16, 2019. Its most recent 510(k) clearance was granted on June 5, 2026.

Summary

Total Recalls
1
510(k) Clearances
6
Inspections
0
Compliance Actions
0

Recent Recalls

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

Recent 510(k) Clearances

K-NumberDeviceDate
K254086EyeBOX SNAPJune 5, 2026
K242116EyeBOX EBX-4.1April 4, 2025
K212310EyeBOX (Model EBX-4)December 22, 2021
K201841EyeBOXSeptember 6, 2020
K191183EyeBOXJuly 31, 2019
DEN170091EyeBOXDecember 28, 2018