Cleared Traditional

ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY WEAR, MULTIFOCAL CONTACT LENS, KERATOCONUS (K110261) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110261 · Soflex Limited · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2011
Decision
181d
Days
Class 2
Risk

K110261 is an FDA 510(k) clearance for the ENI-EYE SH TORIC (EFROFILCON A) SOFT HYDROPHILIC TORIC CONTACT LENS FOR DAILY.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Soflex Limited (Greenwood Village, US). The FDA issued a Cleared decision on July 28, 2011 after a review of 181 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.

View all Soflex Limited devices

Submission Details

510(k) Number K110261 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2011
Decision Date July 28, 2011
Days to Decision 181 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
71d slower than avg
Panel avg: 110d · This submission: 181d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 485
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K110261.
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
PUSCON WATER BALANCE-1DAY TINT (omafilcon A) SOFT (HYDROPHILIC) CONTACT LENS
K253885 · GEO MEDICAL CO., LTD. · Apr 2026
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K254269 · St. shine Optical Co., Ltd. · Mar 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K252385 · Pegavision Corporation · Mar 2026