Cleared Traditional

Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (K223585) - FDA 510(k) Clearance

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

K223585 · Yung Sheng Optical Co., Ltd. · Ophthalmic device
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Dec 2023
Decision
384d
Days
Class 2
Risk

K223585 is an FDA 510(k) clearance for the Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens .... Classified as Lenses, Soft Contact, Daily Wear (product code LPL), Class II - Special Controls.

Submitted by Yung Sheng Optical Co., Ltd. (Taichung City, TW). The FDA issued a Cleared decision on December 20, 2023 after a review of 384 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 Yung Sheng Optical Co., Ltd. devices

Submission Details

510(k) Number K223585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 2022
Decision Date December 20, 2023
Days to Decision 384 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
274d slower than avg
Panel avg: 110d · This submission: 384d
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 99
Devices cleared under the same product code (LPL) and FDA review panel - the closest regulatory comparables to K223585.
Clariti 1 day Multifocal (somofilcon A) Soft (Hydrophilic), Daily Disposable Contact Lens with UV Blocker
K234127 · CooperVision, Inc. · Jan 2024
HOYA Illumina (sorafilcon A) Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Toric Daily Disposable Soft Contact Lens, HOYA Illumina (sorafilcon A) Multifocal Daily Disposable Soft Contact Lens
K223397 · Hoya Lamphun , Ltd. · Jan 2024
Precision1
K233856 · Alcon Laboratories, Inc. · Dec 2023
Samfilcon B Custom Contact Lens
K230954 · Bausch & Lomb, Incorporated · Nov 2023
Innova Vision (inifilcon A) Silicone Hydrogel Soft (Hydrophilic) Contact Lens
K232139 · Innova Vision, Inc. · Nov 2023
DAILIES TOTAL1®
K232921 · Alcon Laboratories, Inc. · Nov 2023