Cleared Traditional

Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Disposable Contac (K182734) - FDA 510(k) Clearance

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

K182734 · Unicon Optical Co., Ltd. · Ophthalmic device
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May 2019
Decision
230d
Days
Class 2
Risk

K182734 is an FDA 510(k) clearance for the Unicon Hydrogel with Unicon Polymer (etafilcon A) Soft (Hydrophilic) Daily Di.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Unicon Optical Co., Ltd. (Hsinchu County, TW). The FDA issued a Cleared decision on May 16, 2019 after a review of 230 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 Unicon Optical Co., Ltd. devices

Submission Details

510(k) Number K182734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 28, 2018
Decision Date May 16, 2019
Days to Decision 230 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
120d slower than avg
Panel avg: 110d · This submission: 230d
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 99
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K182734.
UNICON Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
K191929 · Unicon Optical Co., Ltd. · Sep 2019
Vexillum Zephyr (olifilcon A) with Tangible Polymers Spherical/Toric/Multifocal Silicone Hydrogel Soft Contact Lens
K183670 · Visco Vision, Inc. · Sep 2019
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
MyDay
K190965 · CooperVision, Inc. · Apr 2019
ADORE (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Tinted/color)
K181656 · Eyemed Technologies S.R.L. · Mar 2019
DAILIES Colors, DAILIES Colors Toric, DAILIES Colors Progressives
K190045 · Alcon Laboratories, Inc. · Feb 2019