Cleared Traditional

K142275 - Neo Cosmo (Polymacon) Soft (Hydrophilic...

K142275 is an FDA 510(k) clearance for Neo Cosmo (Polymacon) Soft (Hydrophilic..., manufactured by Neo Vision Co., Ltd.. The device is a Class 2 Ophthalmic device with product code LPL cleared through the Traditional 510(k) pathway after a 53-day FDA review.

K142275 · Neo Vision Co., Ltd. · Ophthalmic device
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Oct 2014
Decision
53d
Days
Class 2
Risk

K142275 is an FDA 510(k) clearance for the Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Neo Vision Co., Ltd. (Gyeonggi-Do, KR). The FDA issued a Cleared decision on October 7, 2014 after a review of 53 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 Neo Vision Co., Ltd. devices

FDA 510(k) Submission Details - K142275

510(k) Number K142275 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 15, 2014
Decision Date October 07, 2014
Days to Decision 53 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
57d faster than avg
Panel avg: 110d · This submission: 53d
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 170
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K142275.
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AIR OPTIX COLORS, AIR OPTIX COLORS TORIC, AIR OPTIX COLORS MULTIFOCAL
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AVAIRA SPHERIC AND TORIC (ENFILCON A) SOFT CONTACT LENS
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K132715 · Bausch & Lomb, Incorporated · Dec 2013