Cleared Traditional

K201013 - Optixon 1-Day

K201013 is the FDA 510(k) clearance for Optixon 1-Day by Optixon, Inc.. It is a Class 2 Ophthalmic device (product code LPL) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K201013 · Optixon, Inc. · Ophthalmic device
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Optimized for regulatory review, auditing and printing
Sep 2020
Decision
154d
Days
Class 2
Risk

K201013 is an FDA 510(k) clearance for the Optixon 1-Day. Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Optixon, Inc. (Daegu, KR). The FDA issued a Cleared decision on September 18, 2020 after a review of 154 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 Optixon, Inc. devices

Submission Details

510(k) Number K201013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 2020
Decision Date September 18, 2020
Days to Decision 154 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
44d slower than avg
Panel avg: 110d · This submission: 154d
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 Consultant

Igc Co., Ltd.
Eunbae Cho

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 160
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K201013.
Ethos Aquell (Hioxifilcon A) One-Day Soft (Hydrophilic) Contact Lenses (59% Water)
K201268 · Plexus Optix, Inc. · Oct 2020
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Pegavision (Etafilcon A) Color Daily Disposable Soft (Hydrophilic) Contact Lenses, Pegavision (Etafilcon A) Color Soft (Hydrophilic) Contact Lenses
K200296 · Pegavision Corporation · Oct 2020
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K201080 · Visco Vision, Inc. · Jul 2020
Miru 1day UpSide (midafilcon A)
K193399 · Menicon Co, Ltd. · Jun 2020
Bausch + Lomb (Kalifilcon A) Soft Contact Lens, Bausch + Lomb (Kalifilcon A) Soft Contact Lens for astigmatism
K200528 · Bausch & Lomb, Incorporated · Jun 2020