K250501 is an FDA 510(k) clearance for the System Sophi. This device is classified as a Unit, Phacofragmentation (Class II - Special Controls, product code HQC).
Submitted by This AG (Heerbrugg, CH). The FDA issued a Cleared decision on November 14, 2025, 267 days after receiving the submission on February 20, 2025.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.4670.
| 510(k) Number | K250501 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2025 |
| Decision Date | November 14, 2025 |
| Days to Decision | 267 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | HQC - Unit, Phacofragmentation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.4670 |