FDA Product Code HLZ: Electrode, Corneal
Leading manufacturers include Retmap, Inc..
11
Total
11
Cleared
145d
Avg days
1976
Since
Stable submission activity - 1 submissions in the last 2 years
Consistent review times:
135d avg (recent)
FDA 510(k) Cleared Electrode, Corneal Devices (Product Code HLZ)
11 devices
Cleared
Apr 01, 2026
RM Electrode (RMH 25-01)
Retmap, Inc.
Ophthalmic
135d
Cleared
Dec 07, 2023
RM Electrode (RMH 23-01)
Retmap, Inc.
Ophthalmic
129d
About Product Code HLZ - Regulatory Context
510(k) Submission Activity
11 total 510(k) submissions under product code HLZ since 1976, with 11 receiving FDA clearance (average review time: 145 days).
Submission volume has remained relatively stable over the observed period, with 1 submissions in the last 24 months.
FDA Review Time
FDA review times for HLZ submissions have been consistent, averaging 135 days recently vs 146 days historically.
HLZ devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →