Cleared Traditional

K142766 - I-55 (methafilcon A) Soft (hydrophilic)...

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
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 Peers - LPL Lenses, Soft Contact, Daily Wear

All 165
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