Cleared Traditional

K162223 - Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A)

K162223 is an FDA 510(k) clearance for Aveo 1-DAY Aspheric Soft Contact Lens (..., manufactured by Supervision Optimax Sdn Bhd. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K162223 · Supervision Optimax Sdn Bhd · Ophthalmic device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2017
Decision
149d
Days
Class 2
Risk

K162223 is an FDA 510(k) clearance for the Aveo 1-DAY Aspheric Soft Contact Lens (omafilcon A). Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Supervision Optimax Sdn Bhd (Sungai Buloh, MY). The FDA issued a Cleared decision on January 4, 2017 after a review of 149 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.

FDA 510(k) Submission Details - K162223

510(k) Number K162223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 2016
Decision Date January 04, 2017
Days to Decision 149 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
39d slower than avg
Panel avg: 110d · This submission: 149d
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 K162223.
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
PolyDev Soft Contact Lenses
K171157 · Polydev , Ltd. · Jun 2017
Aquamax (Etafilcon A) Bi-Weekly Soft, Aquamax (Etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
K161739 · Pegavision Corporation · Dec 2016
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