K243878 is an FDA 510(k) clearance for the CLARUS (700). 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 April 17, 2025, 120 days after receiving the submission on December 18, 2024.
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 | K243878 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 18, 2024 |
| Decision Date | April 17, 2025 |
| Days to Decision | 120 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. |