Submission Details
| 510(k) Number | K252175 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 11, 2025 |
| Decision Date | February 10, 2026 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
K252175 is an FDA 510(k) clearance for the LANDR Contact LENS Case, a Case, Contact Lens (Class II — Special Controls, product code LRX), submitted by Fourth Axis, LLC (Boise, US). The FDA issued a Cleared decision on February 10, 2026, 214 days after receiving the submission on July 11, 2025. This device falls under the Ophthalmic review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K252175 FDA.gov |
| FDA Decision | Cleared SESE |
| Date Received | July 11, 2025 |
| Decision Date | February 10, 2026 |
| Days to Decision | 214 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LRX — Case, Contact Lens |
| Device Class | Class II — Special Controls |
| CFR Regulation | 21 CFR 886.5928 |