K253834 is an FDA 510(k) clearance for the VISUREF 600. This device is classified as a Biomicroscope, Slit-lamp, Ac-powered (Class II - Special Controls, product code HJO).
Submitted by Carl Zeiss Vision GmbH (Aalen, DE). The FDA issued a Cleared decision on March 18, 2026, 107 days after receiving the submission on December 1, 2025.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1850.
| 510(k) Number | K253834 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 2025 |
| Decision Date | March 18, 2026 |
| Days to Decision | 107 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HJO — Biomicroscope, Slit-lamp, Ac-powered |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1850 |