K252385 is an FDA 510(k) clearance for the Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses. This device is classified as a Lenses, Soft Contact, Daily Wear (Class II - Special Controls, product code LPL).
Submitted by Pegavision Corporation (Taoyuan City, TW). The FDA issued a Cleared decision on March 13, 2026, 225 days after receiving the submission on July 31, 2025.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5925.
| 510(k) Number | K252385 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 31, 2025 |
| Decision Date | March 13, 2026 |
| Days to Decision | 225 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | LPL — Lenses, Soft Contact, Daily Wear |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.5925 |