K191194 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 June 25, 2019, 53 days after receiving the submission on May 3, 2019.
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..
| 510(k) Number | K191194 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 03, 2019 |
| Decision Date | June 25, 2019 |
| Days to Decision | 53 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| 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. |