Cleared Traditional

K223585 - Pure Plus UV Aspheric (Otufilcon A) Silicone Soft (hydrophilic) Contact Lens for Daily Wear (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.