Cleared Traditional

K122220 - ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S

K122220 is an FDA 510(k) clearance for ENI-EYE SH SOFT K SEMI SCLERAL (EFROFIL..., 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 237-day FDA review.

K122220 · Soflex Limited · Ophthalmic device
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Mar 2013
Decision
237d
Days
Class 2
Risk

K122220 is an FDA 510(k) clearance for the ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS .... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Soflex Limited (Littleton, US). The FDA issued a Cleared decision on March 19, 2013 after a review of 237 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 - K122220

510(k) Number K122220 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 2012
Decision Date March 19, 2013
Days to Decision 237 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
127d slower than avg
Panel avg: 110d · This submission: 237d
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K122220.
LSH (MANGOFILCON A) SPHERE SOFT (HYDROPHILIC) CONTACT LENS, LSH (MANGOFILCON A) MULTIFOCAL SOFT (HYDROPHILIC) CONTACT LE
K120756 · The Lagado Corp. · May 2013
AQUAMAX (POLYMACON) DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
K123973 · Pegavision Corporation · Apr 2013
SAVIEW-COLORS 42 UV (HEFILCON A) ,TORIC (HEFILCON A), MULTIFOCAL (HEFILCON A)SOFT (HYDROPHILIC) CONTACT LENS
K123484 · St. shine Optical Co., Ltd. · Mar 2013
DAILIES AQUACOMFORT PLUS, DAILIES AQUACOMFORT PLUS TORIC, DAILIES AQUACOMFORT PLUS MULTIFOCAL
K123994 · Ciba Vision Corporation · Feb 2013
FRESHKON 1-DAY ALLURING EYES (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR FRESHKON 1-DAY MOSAIC (ETAFILC
K122315 · Oculus Private Limited · Feb 2013
BAUSCH & LOMB PUREVISION (BALAFILCON A) VISIBILITY TINTED CONTACT LENS, BAUSCH & LOMB PUREVISION TORIC (BALAFILCON A) VI
K122575 · Bausch & Lomb, Inc. · Dec 2012
K122220 · ENI-EYE SH SOFT K SEMI SCLERAL (EFROFILCON A) SOFT (HYDROPHILIC) KERATOCONUS AND IRREGULAR COR ENI-EYE SH SOFT K TORIC S
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