Cleared Abbreviated

K141280 - ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS

K141280 is an FDA 510(k) clearance for ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS, manufactured by Seinoh Optical Co. , Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Abbreviated 510(k) pathway after a 63-day FDA review.

K141280 · Seinoh Optical Co. , Ltd. · Ophthalmic device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
63d
Days
Class 2
Risk

K141280 is an FDA 510(k) clearance for the ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Seinoh Optical Co. , Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on July 18, 2014 after a review of 63 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 Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Seinoh Optical Co. , Ltd. devices

FDA 510(k) Submission Details - K141280

510(k) Number K141280 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2014
Decision Date July 18, 2014
Days to Decision 63 days
Submission Type Abbreviated
Review Panel Ophthalmic (OP)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
47d faster than avg
Panel avg: 110d · This submission: 63d
Pathway characteristics
Standards-based clearance path.

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 170
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