Cleared Traditional

K151586 - Eye Secret 55 UV Aspheric (Methafilcon A) Soft (hydrophilic) Contact Lens (FDA 510(k) Clearance)

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

K151586 · Yung Sheng Optical Co., Ltd. · Ophthalmic device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

Aug 2015

Decision

60d

Days

Class 2

Risk

K151586 is an FDA 510(k) clearance for the Eye Secret 55 UV Aspheric (Methafilcon A) 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 August 10, 2015 after a review of 60 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Yung Sheng Optical Co., Ltd. devices

Submission Details

510(k) Number	K151586 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 11, 2015
Decision Date	August 10, 2015
Days to Decision	60 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

50d faster than avg

Panel avg: 110d · This submission: 60d

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.