Cleared Traditional

K162223 - Aveo 1-DAY Aspheric Soft Contact Lens (...

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
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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.

View all Supervision Optimax Sdn Bhd devices

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 165
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K162223.
Menicon ASRB (asmofilcon A) Silicone Hydrogel Soft Contact Lens
K180004 · Menicon Co, Ltd. · Feb 2018
AIR OPTIX COLORS, AIR OPTIX COLORS Toric, AIR OPTIX COLORS Multifocal
K172600 · Alcon Laboratories, Inc. · Oct 2017
DAILIES AquaComfort Plus (sphere), DAILIES AquaComfort Plus Toric, DAILIES AquaComfort Plus Multifocal
K172066 · Alcon Laboratories, Inc. · Aug 2017
DAILIES AquaComfort Plus, DAILIES AquaComfort Plus Toric, DACP Multifocal, Focus DAILIES, Focus DAILIES Toric, Focus DAILIES Progressives
K161391 · Alcon Laboratories, Inc. · Nov 2016
AIR OPTIX COLORS
K162596 · Alcon Laboratories, Inc. · Oct 2016
Avaira Vitality (fanfilcon A) Soft (Hydrofilic) Contact Lens
K160803 · CooperVision, Inc. · Jul 2016