Cleared Traditional

K142766 - I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear

K142766 is an FDA 510(k) clearance for I-55 (methafilcon A) Soft (hydrophilic)..., manufactured by INTEROJO, Inc.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K142766 · INTEROJO, Inc. · Ophthalmic device
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Mar 2015
Decision
168d
Days
Class 2
Risk

K142766 is an FDA 510(k) clearance for the I-55 (methafilcon A) Soft (hydrophilic) Contact Lenses for Daily Wear. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by INTEROJO, Inc. (Seoul, KR). The FDA issued a Cleared decision on March 12, 2015 after a review of 168 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 INTEROJO, Inc. devices

FDA 510(k) Submission Details - K142766

510(k) Number K142766 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 25, 2014
Decision Date March 12, 2015
Days to Decision 168 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
58d slower than avg
Panel avg: 110d · This submission: 168d
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 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 444
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K142766.
NaturalVue (etafilcon A) Daily Disposable Soft (Hydrophilic) Contact Lenses
K150385 · Visioneering Technologies, Inc. · Apr 2015
BHV VIVID (etafilcon A) Soft (Hydropholic) Contact Lens
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EZvue UV, Soft Daily Wear Contact Lenses (ocufilcon D), EZvue Colors, Soft Daily Wear Contact Lenses (ocufilcon D)
K150293 · I-See Vision Technology, Inc. · Apr 2015
Giselle (polymacon) Daily Wear Soft (hydrophilic) Contact Lenses (Clear and Tinted)
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K143632 · Bausch & Lomb, Incorporated · Feb 2015
Intelliwave4
K142641 · Art Optical Contact Lens, Inc. · Jan 2015