Submission Details
| 510(k) Number | K181444 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | June 01, 2018 |
| Decision Date | January 10, 2019 |
| Days to Decision | 223 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
Cleared
Traditional
K181444 - CLARUS
(FDA 510(k) Clearance)
Jan 2019
Decision
223d
Days
Class 2
Risk
K181444 is an FDA 510(k) clearance for the CLARUS. This device is classified as a Camera, Ophthalmic, Slit-scanning (Class II — Special Controls, product code QER).
Submitted by Carl Zeiss Meditec, Inc. (Dublin, US). The FDA issued a Cleared decision on January 10, 2019, 223 days after receiving the submission on June 1, 2018.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1120. An Ophthalmic Slit-scanning Camera Is An Ac-powered Device Intended To Take Photographs Of The Eye And The Surrounding Area..
Device Classification
| Product Code | QER — Camera, Ophthalmic, Slit-scanning |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.1120 |
| Definition | An Ophthalmic Slit-scanning Camera Is An Ac-powered Device Intended To Take Photographs Of The Eye And The Surrounding Area. |
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