Cleared Traditional

K181920 - Clariti 1 day (somofilcon A) Soft (Hydr...

K181920 is the FDA 510(k) clearance for Clariti 1 day (somofilcon A) Soft (Hydr... by CooperVision, Inc.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K181920 · CooperVision, Inc. · Ophthalmic device
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Dec 2018
Decision
146d
Days
Class 2
Risk

K181920 is an FDA 510(k) clearance for the Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by CooperVision, Inc. (Pleasanton, US). The FDA issued a Cleared decision on December 11, 2018 after a review of 146 days - within the typical 510(k) review window.

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 CooperVision, Inc. devices

Submission Details

510(k) Number K181920 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 18, 2018
Decision Date December 11, 2018
Days to Decision 146 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
36d slower than avg
Panel avg: 110d · This submission: 146d
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 160
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K181920.
ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)
K181656 · Eyemed Technologies S.R.L. · Mar 2019
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives
K190045 · Alcon Laboratories, Inc. · Feb 2019
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric
K182782 · Alcon Laboratories, Inc. · Jan 2019
Precision1
K182902 · Alcon Laboratories, Inc. · Dec 2018
Ultra (samfilcon A) Multifocal for Astigmatism Contact Lens
K182249 · Bausch & Lomb, Incorporated · Nov 2018
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus FreshTech, DAILIES AquaComfort Plus Toric and DAILIES AquaComfort Plus Multifocal
K181454 · Alcon Laboratories, Inc. · Nov 2018