K250495 is an FDA 510(k) clearance for the MINI VP1 (PL67_F). This device is classified as a Case, Contact Lens (Class II - Special Controls, product code LRX).
Submitted by Avizor S.A. (Leganés, ES). The FDA issued a Cleared decision on August 1, 2025, 162 days after receiving the submission on February 20, 2025.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5928.
| 510(k) Number | K250495 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | February 20, 2025 |
| Decision Date | August 01, 2025 |
| Days to Decision | 162 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 |