Cleared Traditional

K110835 - GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS (FDA 510(k) Clearance)

Class II Ophthalmic device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K110835 · GEO MEDICAL CO., LTD. · Ophthalmic device
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Apr 2012
Decision
398d
Days
Class 2
Risk

K110835 is an FDA 510(k) clearance for the GEO MAGIC COLOR (POLYMACON) SOFT (HYDROPHILIC) CONTACT LENS. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by GEO MEDICAL CO., LTD. (Mission Viejo, US). The FDA issued a Cleared decision on April 26, 2012 after a review of 398 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 GEO MEDICAL CO., LTD. devices

Submission Details

510(k) Number K110835 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 25, 2011
Decision Date April 26, 2012
Days to Decision 398 days
Submission Type Traditional
Review Panel Ophthalmic (OP)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
288d slower than avg
Panel avg: 110d · This submission: 398d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 482
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K110835.
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DAILIES TOTAL1®
K254052 · Alcon Laboratories, Inc. · Feb 2026
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K251683 · Bruno Vision Care, LLC · Dec 2025
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K250364 · St. shine Optical Co., Ltd. · Oct 2025