K233911 is an FDA 510(k) clearance for the VISULAS combi. This device is classified as a Laser, Ophthalmic (Class II - Special Controls, product code HQF).
Submitted by Carl Zeiss Meditec, AG (Jena, DE). The FDA issued a Cleared decision on September 6, 2024, 269 days after receiving the submission on December 12, 2023.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4390.
| 510(k) Number | K233911 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 12, 2023 |
| Decision Date | September 06, 2024 |
| Days to Decision | 269 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQF — Laser, Ophthalmic |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4390 |