Cleared Traditional

K181558 - Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (methafilcon A) Daily Wear Contact Lens, Sofclear Comfort (methafilcon A) Daily Wear Contact Lens (FDA 510(k) Clearance)

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

K181558 · Gelflex Laboratories · Ophthalmic device
Sep 2018
Decision
85d
Days
Class 2
Risk

K181558 is an FDA 510(k) clearance for the Sofclear Enhance (methafilcon A) Daily Wear Contact Lens, Sofclear Colors (me.... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Gelflex Laboratories (Malaga, AU). The FDA issued a Cleared decision on September 6, 2018 after a review of 85 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.

Submission Details

510(k) Number K181558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 13, 2018
Decision Date September 06, 2018
Days to Decision 85 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 156d · This submission: 85d
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 25
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K181558.
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K254269 · St. shine Optical Co., Ltd. · Mar 2026
Pegavision (Toufilcon B) Daily Disposable Soft (Hydrophilic) Contact Lenses
K252385 · Pegavision Corporation · Mar 2026
DAILIES TOTAL1®
K254052 · Alcon Laboratories, Inc. · Feb 2026
Deseyne (vifilcon C) Daily Disposable Soft (hydrophilic) Contact Lens with UV Blocking for Presbyopia (EDOF)
K251683 · Bruno Vision Care, LLC · Dec 2025
Saview SH Optic 38 UV (Senofilcon A) Visibility Tinted Soft (Hydrophilic) Contact Lens
K250364 · St. shine Optical Co., Ltd. · Oct 2025
Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (Daily Wear)
K244009 · Yung Sheng Optical Co., Ltd. · Sep 2025