Cleared Traditional

K133740 - SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT

K133740 is an FDA 510(k) clearance for SAUFLON CLARITI WITH TINT, manufactured by Sauflon Pharmaceuticals, Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K133740 · Sauflon Pharmaceuticals, Ltd. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Mar 2014
Decision
86d
Days
Class 2
Risk

K133740 is an FDA 510(k) clearance for the SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI M.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Sauflon Pharmaceuticals, Ltd. (Twickenham, Middlesex, GB). The FDA issued a Cleared decision on March 5, 2014 after a review of 86 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 - K133740

510(k) Number K133740 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 09, 2013
Decision Date March 05, 2014
Days to Decision 86 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 110d · This submission: 86d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ophthalmic devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT01996787 Completed Interventional Industry-sponsored

Clinical Study of Visibility Tinted Clariti Contact Lens

The Clinical Performance of the Clariti Contact Lens (Including Handling Tint) for Daily Wear

38
Patients (actual)
1
Site
Open label
Masking
Condition studied Hyperopia; Myopia
Study design Parallel
Eligibility All sexes · 19 Years+ · Healthy volunteers accepted
Principal investigator Philip Morgan, PhD
Sponsor Sauflon Pharmaceuticals Ltd (industry)
Started 2013-06-01 → Primary completion 2013-07-01 → Completed 2013-09-01
Primary outcome
Slit lamp Biomicroscopy
Secondary outcome
Subjective Scores
Study completed - no results published. This trial concluded in 2013 but has not posted results to ClinicalTrials.gov. Completed studies without public results are common in industry-sponsored device trials; the data may be referenced in the 510(k) Summary PDF or remain unpublished.
View full study on ClinicalTrials.gov

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 K133740.
FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS
K133403 · Firestone Optics, Inc. · Jun 2014
EYE SECRET 55 UV ASPHERIC (METHAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS
K133735 · Yung Sheng Optical Co., Ltd. · Mar 2014
ISENS (POLYMACON) SPHERICAL AND TORIC DAILY WEAR SOFT CONTACT LENSES (CLEAR, TINTED, AND COSMETIC TINTED)
K132714 · Vision Science Co., Ltd. · Mar 2014
SAUFLON CLARITI 1 DAY WITH TINT (TORIC/MULTIFOCAL)
K133472 · Souflon Pharmaceuticals, Ltd. · Mar 2014
AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
K133176 · Ciba Vision Corporation · Jan 2014
EYE SECRET 38 UV ASPHERIC (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS FOR DAILY WEAR
K132854 · Yung Sheng Optical Co., Ltd. · Dec 2013
K133740 · SAUFLON CLARITI WITH TINT, SAUFLON CLARITI TORIC WITH TINT, SAUFLON CLARITI MULTIFOCAL WITH TINT
Download PDF FDA Summary Sauflon Pharmaceutica…