Cleared Traditional

K172600 - AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal

K172600 is an FDA 510(k) clearance for AIR OPTIX COLORS, manufactured by Alcon Laboratories, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K172600 · Alcon Laboratories, Inc. · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Oct 2017
Decision
56d
Days
Class 2
Risk

K172600 is an FDA 510(k) clearance for the AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal. 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 October 25, 2017 after a review of 56 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 - K172600

510(k) Number K172600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 30, 2017
Decision Date October 25, 2017
Days to Decision 56 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
54d faster than avg
Panel avg: 110d · This submission: 56d
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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K172600.
Tangible Hydrogel with Tangible Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens
K172692 · Tangible Science, LLC · Dec 2017
OxyPure Color Silicone Hydrogel Soft Contact Lenses
K171447 · Visco Vision, Inc. · Dec 2017
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
K173086 · Visioneering Technologies, Inc. · Nov 2017
Tangible Hydrogel w/ Hydra-PEG (etafilcon A) Soft (Hydrophilic) Daily Wear Contact Lens
K171125 · Tangible Science, LLC · Oct 2017
Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan (hioxifilcon A) Daily Wear Soft (hydrophilic) Contact Lens for ASTIGMATISM, Largan (hioxifilcon A) Daily Wear Soft (Hydrophilic) Contact Lens for PRESBYOPIA
K170286 · Largan Medical Co., Ltd. · Sep 2017
DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
K172066 · Alcon Laboratories, Inc. · Aug 2017