Cleared Traditional

Eye Secret 59 UV Aspheric (Omafilcon A) Soft (Hydrophilic) Contact Lens for Daily Wear (K213983) - 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.

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 K213983.
POLYVUE (polymacon) Soft (hydrophilic) Contact Lens, POLYVUE COLOR (polymacon) Soft (hydrophilic) Contact Lens
K221517 · INTEROJO, Inc. · Oct 2022
AIR OPTIX COLORS
K222500 · Alcon Laboratories, Inc. · Sep 2022
BARBIE (polymacon) Daily Wear Soft (Hydrophilic) Contact Lens
K220143 · Shenzhen Dashicheng Optical Technology Co., Ltd. · Sep 2022
TREVUES (polymacon) Soft (hydrophilic) Contact Lenses (Tinted, Color)
K220045 · Dk Medivision Co., Ltd. · Aug 2022
Innova Vision Hydrogel (Hioxifilcon A) Soft (Hydrophilic) Contact Lens
K213119 · Innova Vision, Inc. · May 2022
MyDay (stenfilcon A) Soft (Hydrophilic) Daily Disposable Contact Lens, Avaira Vitality (fanfilcon A) Soft (Hydrophilic) Contact Lens
K220070 · CooperVision, Inc. · Feb 2022