Cleared Traditional

K181656 - ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)

K181656 is an FDA 510(k) clearance for ADORE (polymacon) Daily Wear Soft (hydr..., manufactured by Eyemed Technologies S.R.L.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 256-day FDA review.

K181656 · Eyemed Technologies S.R.L. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2019
Decision
256d
Days
Class 2
Risk

K181656 is an FDA 510(k) clearance for the ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color). Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Eyemed Technologies S.R.L. (Casorate Sempione, IT). The FDA issued a Cleared decision on March 5, 2019 after a review of 256 days - an extended review 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: 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 Eyemed Technologies S.R.L. devices

FDA 510(k) Submission Details - K181656

510(k) Number K181656 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 22, 2018
Decision Date March 05, 2019
Days to Decision 256 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
146d slower than avg
Panel avg: 110d · This submission: 256d
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 349
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K181656.
Apioc (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc P for Presbyopia (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc A for Astigmatism (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens, Apioc AP (efrofilcon A) Soft (hydrophilic) Silicone Hydrogel Contact Lens
K191121 · Lentechs, LLC · Sep 2019
Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac
K182734 · Unicon Optical Co., Ltd. · May 2019
MyDay
K190965 · CooperVision, Inc. · Apr 2019
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives
K190045 · Alcon Laboratories, Inc. · Feb 2019
DAILIES TOTAL1, DAILIES TOTAL1 Asphere, DAILIES TOTAL1 for ASTIGMATISM, DAILIES TOTAL1 Multifocal, DAILIES TOTAL1 Multifocal Toric
K182782 · Alcon Laboratories, Inc. · Jan 2019
Clariti 1 day (somofilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens with UV Blocker
K181920 · CooperVision, Inc. · Dec 2018