Cleared Special

K190045 - DAILIES Colors

K190045 is the FDA 510(k) clearance for DAILIES Colors by Alcon Laboratories, Inc.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Special 510(k) pathway after a 28-day FDA review.

K190045 · Alcon Laboratories, Inc. · Ophthalmic device
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Feb 2019
Decision
28d
Days
Class 2
Risk

K190045 is an FDA 510(k) clearance for the DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Alcon Laboratories, Inc. (Fort Worth, US). The FDA issued a Cleared decision on February 6, 2019 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Alcon Laboratories, Inc. devices

Submission Details

510(k) Number K190045 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2019
Decision Date February 06, 2019
Days to Decision 28 days
Submission Type Special
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
82d faster than avg
Panel avg: 110d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 K190045.
Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac
K182734 · Unicon Optical Co., Ltd. · May 2019
MyDay
K190965 · CooperVision, Inc. · Apr 2019
ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)
K181656 · Eyemed Technologies S.R.L. · Mar 2019
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric
K182782 · Alcon Laboratories, Inc. · Jan 2019
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
K181920 · CooperVision, Inc. · Dec 2018
Precision1
K182902 · Alcon Laboratories, Inc. · Dec 2018