Cleared Traditional

K260311 - Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

Also marketed or referenced as:

Saview 60 UV toric (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens Saview 60 UV multifocal (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens

K260311 is an FDA 510(k) clearance for Saview 60 UV (Omafilcon A) Visibility T..., manufactured by St. shine Optical Co., Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 271-day FDA review.

K260311 · St. shine Optical Co., Ltd. · Ophthalmic device

Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)

Optimized for regulatory review, auditing and printing

Oct 2026

Decision

271d

Days

Class 2

Risk

K260311 is an FDA 510(k) clearance for the Saview 60 UV (Omafilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by St. shine Optical Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on October 28, 2026 after a review of 271 days - an extended review cycle.

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. Standard predicate reliance. 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 - K260311

510(k) Number	K260311 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 30, 2026
Decision Date	October 28, 2026
Days to Decision	271 days
Submission Type	Traditional
Review Panel	Ophthalmic (OP)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

161d slower than avg

Panel avg: 110d · This submission: 271d

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 K260311.

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

K253875 · Visco Vision, Inc. · 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

FDA 510(k) Resources - Ophthalmic

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.