Cleared Traditional

K011256 - TORIC LITE LENS

K011256 is an FDA 510(k) clearance for TORIC LITE LENS, manufactured by Soflex Contact Lens Industries , Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K011256 · Soflex Contact Lens Industries , Ltd. · Ophthalmic device
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Jul 2001
Decision
84d
Days
Class 2
Risk

K011256 is an FDA 510(k) clearance for the TORIC LITE LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Soflex Contact Lens Industries , Ltd. (Littleton, US). The FDA issued a Cleared decision on July 17, 2001 after a review of 84 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K011256

510(k) Number K011256 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2001
Decision Date July 17, 2001
Days to Decision 84 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
26d faster than avg
Panel avg: 110d · This submission: 84d
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 K011256.
EYE-Q (XYLOFILCON A) SOFT (HYDROPHILIC) MULTIFOCAL CONTACT LENS FOR DAILY WEAR
K013469 · Soflex Contact Lens Industries , Ltd. · Nov 2001
BIOMEDICS UV MULTIFOCAL
K012425 · Ocular Sciences Puerto Rico, Inc. · Oct 2001
GELFLEX TRITON HW SOFT BIFOCAL CONTACT LENS AND THE GELFLEX TRITON SOFT BIFOCAL CONTACT LENS
K011072 · Gelflex · Aug 2001
S45 (OCUFILCON A) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR (CLEAR AND TINTED, FULLY-
K001962 · Bescon Co., Ltd. · Jul 2001
S38 (POLYMACON) SPHERICAL, ASPHERICAL, TORIC AND MULTIFOCAL SOFT CONTACT LENS FOR DAILY WEAR(CLEAR AND TINTED, FULLY-
K002099 · Bescon Co., Ltd. · Jul 2001
SPECIALTY D-UV (OCUFILCON D) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR, SPECIALTY D-UV MULTIFOCAL (OCUFLICON D)
K011542 · Specialty Ultravision, Inc. · Jun 2001
K011256 · TORIC LITE LENS
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