Ophthalmology

CLARUS (700)

Carl Zeiss Meditec, Inc.

FDA-cleared AI medical device

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

FDA Submission Metadata

Submission number
K243878
Decision date
April 2025
FDA panel
Ophthalmic
Product code
QER

This entry is sourced from the FDA AI/ML-Enabled Medical Devices list. No editorial review yet — the catalogue may add a deeper review of this device in future.

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