Cleared Traditional

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

K110261 is an FDA 510(k) clearance for ENI-EYE SH TORIC (EFROFILCON A) SOFT HY..., manufactured by Soflex Limited. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K110261 · Soflex Limited · Ophthalmic device
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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

FDA 510(k) Submission Details - K110261

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.

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 171
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K110261.
AVAIRA AVAIRA TORIC AVAIRA MULTIFOCAL
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