QER · Class II · 21 CFR 886.1120

FDA Product Code QER: Camera, Ophthalmic, Slit-scanning

An Ophthalmic Slit-scanning Camera Is An Ac-powered Device Intended To Take Photographs Of The Eye And The Surrounding Area.

Leading manufacturers include Carl Zeiss Meditec, Inc..

3
Total
3
Cleared
132d
Avg days
2019
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Consistent review times: 120d avg (recent)

FDA 510(k) Cleared Camera, Ophthalmic, Slit-scanning Devices (Product Code QER)

3 devices
1–3 of 3
Cleared Apr 17, 2025
CLARUS (700)
K243878
Carl Zeiss Meditec, Inc.
Ophthalmic · 120d

About Product Code QER - Regulatory Context

510(k) Submission Activity

3 total 510(k) submissions under product code QER since 2019, with 3 receiving FDA clearance (average review time: 132 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

FDA review times for QER submissions have been consistent, averaging 120 days recently vs 138 days historically.

QER devices are reviewed by the Ophthalmic panel. Browse all Ophthalmic devices →