Cleared Traditional

Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses (K180985) - FDA 510(k) Clearance

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180985 · Supervision Optimax Sdn Bhd · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2018
Decision
56d
Days
Class 2
Risk

K180985 is an FDA 510(k) clearance for the Aveo (omafilcon A) Soft (Hydrophilic) Contact Lenses. 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 June 8, 2018 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.

View all Supervision Optimax Sdn Bhd devices

Submission Details

510(k) Number K180985 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 13, 2018
Decision Date June 08, 2018
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.

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 139
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K180985.
Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Astigmatism, Largan 55 UV (ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens for Presbyopia
K181232 · Largan Medical Co., Ltd. · Jun 2018
Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lensfor ASTIGMATISM, Largan 55 (methafilcon A) Daily Wear Soft (hydrophilic) Contact Lens for PRESBYOPIA
K181230 · Largan Medical Co., Ltd. · Jun 2018
Desio (hioxifilcon D) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
K181050 · Qualimed Srl · Jun 2018
One Day Flat Pack (hioxifilcon A) Daily Disposable Soft Contact Lens
K180819 · Menicon Co, Ltd. · May 2018
Focus DAILIES / Focus DAILIES Toric / Focus DAILIES Progressives, DAILIES AquaComfort Plus (DACP) / DACP Toric / DACP Multifocal, FreshLook One-Day, DAILIES Total 1 / DAILIES Total 1 Multifocal
K180669 · Alcon Laboratories, Inc. · Apr 2018
Si-Hy (olifilcon B) color silicone hydrogel soft contact lens
K180322 · Visco Vision, Inc. · Apr 2018