Cleared Traditional

K142275 - Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens

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
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

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
Combination Product No
PCCP Authorized No
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 Consultant

Albert Rego PHD
Albert Rego

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 486
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K142275.
UNICON (ETAFILCON A) SOFT (HYDROPHILIC) CONTACT LENS WITH UV BLOCKER FOR DAILY WEAR
K141917 · Unicon Optical Co., Ltd. · Oct 2014
AQUAMAX (ETAFILCON A) BI-WEEKLY DISPOSABLE SOFT (HYDROPHILIC) CONTACT LENSES
K140025 · Pegavision Corporation · Oct 2014
VASSEN COLOR
K141699 · Vassen Co., Ltd. · Oct 2014
ACUVUE (ETAFILCON A) SOFT CONTACT LENS FOR PRESBYOPIA
K141670 · Johnson & Johnson Vision Care, Inc. · Sep 2014
ILENS (OCUFILCON D) DAILY SOFT CONTACT LENS
K141280 · Seinoh Optical Co. , Ltd. · Jul 2014
FIRESOFT-SIHY. IC DAILY WEAR CONTACT LENSES, FIRESOFT-55 DAILY WEAR CONTACT LENSES, FIRESOFT-49G DAILY WEAR CONTACT LENS
K133403 · Firestone Optics, Inc. · Jun 2014
K142275 · Neo Cosmo (Polymacon) Soft (Hydrophilic) Contact Lens
Download PDF FDA Summary Neo Vision Co., Ltd.