Cleared Traditional

K181920 - Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker

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

K181920 · CooperVision, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

FDA 510(k) Submission Details - K181920

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.

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 348
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