Cleared Special

K162596 - AIR OPTIX COLORS

K162596 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 Special 510(k) pathway after a 27-day FDA review.

K162596 · Alcon Laboratories, Inc. · Ophthalmic device
Download Printable Device Report (PDF)
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Oct 2016
Decision
27d
Days
Class 2
Risk

K162596 is an FDA 510(k) clearance for the AIR OPTIX COLORS. 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 13, 2016 after a review of 27 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

FDA 510(k) Submission Details - K162596

510(k) Number K162596 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 16, 2016
Decision Date October 13, 2016
Days to Decision 27 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
83d faster than avg
Panel avg: 110d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 Consultant

Alcon / Ciba Vision GmbH
Andreas Friese

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 342
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K162596.
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
K161391 · Alcon Laboratories, Inc. · Nov 2016
Visco (olifilcon A) soft contact lens
K160245 · Visco Vision, Inc. · Oct 2016
Saview-Colors Aqua 42 UV (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Toric (hefilcon A) Soft (Hydrophilic) Contact Lens, Saview-Colors Aqua 42 UV Multifocal (hefilcon A) Soft (Hydrophilic) Contact Lens
K162317 · St. shine Optical Co., Ltd. · Oct 2016
Toricolors (hioxifilcon D) Soft Contact Lenses
K161931 · Polydev , Ltd. · Oct 2016
EYEREVE (hioxifilcon D) Soft (hydrophilic) Contact Lens for Daily Wear
K161124 · Vision Science Co., Ltd. · Aug 2016
ChicView (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/Color)
K161098 · Joowon Innovation Co., Ltd. · Aug 2016