Cleared Traditional

K253875 - OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens

Also marketed or referenced as:
OxyPure (olifilcon A) Toric Biweekly Silicone Hydrogel Soft Contact Lens OxyPure (olifilcon A) Multifocal Biweekly Silicone Hydrogel Soft Contact Lens

K253875 is an FDA 510(k) clearance for OxyPure (olifilcon A) Spherical Biweekl..., manufactured by Visco Vision, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 323-day FDA review.

K253875 · Visco Vision, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2026
Decision
323d
Days
Class 2
Risk

K253875 is an FDA 510(k) clearance for the OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Visco Vision, Inc. (Taoyuan City, TW). The FDA issued a Cleared decision on October 23, 2026 after a review of 323 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Ophthalmic FDA review panel, regulated under 21 CFR 886.5925 - the FDA ophthalmic device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Ophthalmic review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K253875

510(k) Number K253875 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 2025
Decision Date October 23, 2026
Days to Decision 323 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
213d slower than avg
Panel avg: 110d · This submission: 323d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LPL Device Classification - Class 2, Special Controls

Product Code LPL Lenses, Soft Contact, Daily Wear
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 886.5925
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ophthalmic devices follow this clearance model.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 489
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K253875.
Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K260311 · St. shine Optical Co., Ltd. · Oct 2026
Bausch + Lomb Multifocal for Astigmatism (kalifilcon A) One-Day Soft (hydrophilic) Contact Lens
K262941 · Bausch & Lomb, Inc. · Oct 2026
Miru 1day UpSide (midafilcon A)
K262495 · Menicon Co, Ltd. · Sep 2026
Interojo 45 (inofilcon A) Soft (Hydrophilic) Silicone Hydrogel Contact Lens with GrabSoo Plus
K260507 · INTEROJO, Inc. · May 2026
Pegavision (Polymacon) Daily Disposable Soft (Hydrophilic) Contact Lenses
K253352 · Pegavision Corporation · May 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K261299 · Pegavision Corporation · May 2026
K253875 · OxyPure (olifilcon A) Spherical Biweekly Silicone Hydrogel Soft Contact Lens
Download PDF FDA Summary Visco Vision, Inc.