510(k) clearance
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
- 510(k) number
- K253875
- Applicant
- Visco Vision, Inc.
- Decision date
- Oct 23, 2026
- Date received
- Dec 4, 2025
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Product code
- LPL
- Device type
- Lenses, Soft Contact, Daily Wear
- Device class
- Class II
- Regulation
- 21 CFR 886.5925
- Advisory committee
- Ophthalmic
- Statement or summary
- Summary
- Third party
- N
- Location
- Taoyuan City, TW