Devices · Carl Zeiss Meditec, Inc

CLARUS

Carl Zeiss Meditec, Inc is listed for CLARUS (K191194). The FDA list gives June 25, 2019 as the date of the final decision. The lead panel is Ophthalmic, and the database link on the FDA list is the 510(k) pathway. openFDA describes product code QER as “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. openFDA records this submission’s decision description as “Substantially Equivalent.” This paragraph is assembled only from those public fields. It is not an FDA review, not a determination of safety or effectiveness, and not medical advice. Official record: https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPMN/pmn.cfm?ID=K191194

Official FDA database record

Date of final decision

June 25, 2019

Company on the FDA list

Carl Zeiss Meditec, Inc

Lead panel

Ophthalmic

Primary product code

QER

openFDA device name for the code

Camera, Ophthalmic, Slit-Scanning

Device class

2

Regulation number

886.1120

openFDA decision description

Substantially Equivalent

openFDA decision code

SESE

Statement or summary label

Summary