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QER — Camera, Ophthalmic, Slit-Scanning Class II

FDA Device Classification

Classification Details

Product Code
QER
Device Class
Class II
Regulation Number
886.1120
Submission Type
Review Panel
OP
Medical Specialty
Ophthalmic
Implant
No

Definition

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

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K243878carl zeiss meditecCLARUS (700)April 17, 2025
K191194carl zeiss meditecCLARUSJune 25, 2019
K181444carl zeiss meditecCLARUSJanuary 10, 2019