Cleared Traditional

K232839 - Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon) 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.

K232839 · Yung Sheng Optical Co., Ltd. · Ophthalmic device

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Dec 2024

Decision

459d

Days

Class 2

Risk

K232839 is an FDA 510(k) clearance for the Eye Secret 38 UV Aspheric (polymacon) and Air Light 38 UV Aspheric (polymacon.... 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 16, 2024 after a review of 459 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Ophthalmic submissions.

View all Yung Sheng Optical Co., Ltd. devices

Submission Details

510(k) Number	K232839 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 14, 2023
Decision Date	December 16, 2024
Days to Decision	459 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

349d slower than avg

Panel avg: 110d · This submission: 459d

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.