QER

Camera, Ophthalmic, Slit-Scanning

Product code
QER
Device name
Camera, Ophthalmic, Slit-Scanning
Device class
Class 2
21 CFR
21 CFR 886.1120
Medical specialty
Ophthalmic
Marketing pathway
510(K)
Flag
Third-party review eligible
510(k) clearances (last 3 years)
1
Summaries archived here
1 (direct download)
510(k) clearances (all years, FDA)
3 (all years; only the last 3 years are listed here)

FDA classification definition

An ophthalmic slit-scanning camera is an AC-powered device intended to take photographs of the eye and the surrounding area.

Definition text from the FDA device classification database (U.S. federal government work, public domain).

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2025-04-17.

NumberDecision dateApplicantDevice nameSummary
K2438782025-04-17Carl Zeiss Meditec, Inc.CLARUS (700)PDF

1 summaries are archived here for direct download.

Official FDA classification page: QER
Classification and pathway per current FDA publications. Data from openFDA (CC0).