Cleared Traditional

K213983 - Eye Secret 59 UV Aspheric (Omafilcon A) 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.

K213983 · Yung Sheng Optical Co., Ltd. · Ophthalmic device

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Sep 2022

Decision

256d

Days

Class 2

Risk

K213983 is an FDA 510(k) clearance for the Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for D.... 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 September 2, 2022 after a review of 256 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 Yung Sheng Optical Co., Ltd. devices

Submission Details

510(k) Number	K213983 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	December 20, 2021
Decision Date	September 02, 2022
Days to Decision	256 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

146d slower than avg

Panel avg: 110d · This submission: 256d

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.