Cleared Traditional

K181558 - Sofclear Enhance (methafilcon A) Daily ...

K181558 is the FDA 510(k) clearance for Sofclear Enhance (methafilcon A) Daily ... by Gelflex Laboratories. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K181558 · Gelflex Laboratories · Ophthalmic device
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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.

View all Gelflex Laboratories devices

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 110d · 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 Consultant

Eyereg Consulting, Inc.
Bret Andre

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - LPL Lenses, Soft Contact, Daily Wear

All 160
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K181558.
Largan 55 UV Color (Ocufilcon D) Daily Wear Soft (hydrophilic) Contact Lens
K182523 · Largan Medical Co., Ltd. · Nov 2018
ILICON (ocufilcon D) Soft (Hydrophilic) Daily Wear Contact Lenses (Tinted, Color)
K182247 · Vizionfocus, Inc. · Oct 2018
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K181349 · Visco Vision, Inc. · Sep 2018
FreshLook Handling Tint, FreshLook Colors, FreshLook ColorBlends, FreshLook Dimensions
K181796 · Alcon Laboratories, Inc. · Aug 2018
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