# OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens (K253875): 510(k) cleared for Visco Vision, Inc.

**Predicate Speed & CAPA Advisory Opportunity Score:** 67/100

| Field | Value |
|---|---|
| Record | 510(k) clearance |
| 510(k) number | K253875 |
| Device | OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens; OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens |
| Applicant | Visco Vision, Inc. |
| Specialty / panel | Ophthalmic |
| Product code | LPL |
| Device class | 2 |
| Clearance type | Traditional |
| Decision | Substantially Equivalent |
| Received | 2025-12-04 |
| Decision date | 2026-10-23 |
| Review time (days) | 323 |
| Third-party review | No |
| Applicant location | Taoyuan City, TW |

## Why this score
- A long 323-day review suggests additional-information requests: a firm likely to value regulatory help next time.
- Posted 12 days ago.

Source: U.S. FDA openFDA (510(k) clearances and device enforcement reports) (https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K253875). Last refreshed: 2026-11-04T09:16:12.111Z.
Data from the FDA openFDA API, which may lag official FDA databases. Informational only; not regulatory or legal advice.